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. 2022 Feb 24;2(2):CD012857.
doi: 10.1002/14651858.CD012857.pub2.

Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults

Kim Boesen  1   2 , Asger Sand Paludan-Müller  3   4 , Peter C Gøtzsche  5 , Karsten Juhl Jørgensen  3   4
Affiliations

Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults

Kim Boesen et al. Cochrane Database Syst Rev. .

Abstract

Background: Attention deficit hyperactivity disorder (ADHD) is a psychiatric diagnosis increasingly used in adults. The recommended first-line pharmacological treatment is central nervous system (CNS) stimulants, such as methylphenidate, but uncertainty remains about its benefits and harms.

Objectives: To assess the beneficial and harmful effects of extended-release formulations of methylphenidate in adults diagnosed with ADHD.

Search methods: We searched CENTRAL, MEDLINE, Embase, nine other databases and four clinical trial registries up to February 2021. We searched 12 drug regulatory databases for clinical trial data up to 13 May 2020. In addition, we cross-referenced all available trial identifiers, handsearched reference lists, searched pharmaceutical company databases, and contacted trial authors.

Selection criteria: Randomised, double-blind, parallel-group trials comparing extended-release methylphenidate formulations at any dose versus placebo and other ADHD medications in adults diagnosed with ADHD.

Data collection and analysis: Two review authors independently extracted data. We assessed dichotomous outcomes as risk ratios (RRs), and rating scales and continuous outcomes as mean differences (MDs) or standardised mean differences (SMDs). We used the Cochrane risk of bias tool to assess risks of bias, and GRADE to assess the certainty of the evidence. We meta-analysed the data using a random-effects model. We assessed three design characteristics that may impair the trial results' 'generalisability'; exclusion of participants with psychiatric comorbidity; responder selection based on previous experience with CNS stimulants; and risk of withdrawal effects. Our prespecified primary outcomes were functional outcomes, self-rated ADHD symptoms, and serious adverse events. Our secondary outcomes included quality of life, ADHD symptoms rated by investigators and by peers such as family members, cardiovascular variables, severe psychiatric adverse events, and other adverse events.

Main results: We included 24 trials (5066 participants), of which 21 reported outcome data for this review. We also identified one ongoing study. We included documents from six drug regulatory agencies covering eight trials. Twenty-one trials had an outpatient setting and three were conducted in prisons. They were primarily conducted in North America and Europe. The median participant age was 36 years. Twelve trials (76% of participants) were industry-sponsored, four (14% of participants) were publicly funded with industry involvement, seven (10% of participants) were publicly funded, and one had unclear funding. The median trial duration was eight weeks. One trial was rated at overall unclear risk of bias and 20 trials were rated at overall high risk of bias, primarily due to unclear blinding of participants and investigators, attrition bias, and selective outcome reporting. All trials were impaired in at least one of the three design characteristics related to 'generalisability'; for example, they excluded participants with psychiatric comorbidity such as depression or anxiety, or included participants only with a previous positive response to methylphenidate, or similar drugs. This may limit the trials' usefulness for clinical practice, as they may overestimate the benefits and underestimate the harms. Extended-release methylphenidate versus placebo (up to 26 weeks) For the primary outcomes, we found very low-certainty evidence that methylphenidate had no effect on 'days missed at work' at 13-week follow-up (mean difference (MD) -0.15 days, 95% confidence interval (CI) -2.11 to 1.81; 1 trial, 409 participants) or serious adverse events (risk ratio (RR) 1.43, CI 95% CI 0.85 to 2.43; 14 trials, 4078 participants), whereas methylphenidate improved self-rated ADHD symptoms (small-to-moderate effect; SMD -0.37, 95% CI -0.43 to -0.30; 16 trials, 3799 participants). For secondary outcomes, we found very low-certainty evidence that methylphenidate improved self-rated quality of life (small effect; SMD -0.15, 95% CI -0.25 to -0.05; 6 trials, 1888 participants), investigator-rated ADHD symptoms (small-to-moderate effect; SMD -0.42, 95% CI -0.49 to -0.36; 18 trials, 4183 participants), ADHD symptoms rated by peers such as family members (small-to-moderate effect; SMD -0.31, 95% CI -0.48 to -0.14; 3 trials, 1005 participants), and increased the risk of experiencing any adverse event (RR 1.27, 95% CI 1.19 to 1.37; 14 trials, 4214 participants). We rated the certainty of the evidence as 'very low' for all outcomes, primarily due to high risk of bias and 'indirectness of the evidence'. One trial (419 participants) had follow-up at 52 weeks and two trials (314 participants) included active comparators, hence long-term and comparative evidence is limited.

Authors' conclusions: We found very low-certainty evidence that extended-release methylphenidate compared to placebo improved ADHD symptoms (small-to-moderate effects) measured on rating scales reported by participants, investigators, and peers such as family members. Methylphenidate had no effect on 'days missed at work' or serious adverse events, the effect on quality of life was small, and it increased the risk of several adverse effects. We rated the certainty of the evidence as 'very low' for all outcomes, due to high risk of bias, short trial durations, and limitations to the generalisability of the results. The benefits and harms of extended-release methylphenidate therefore remain uncertain.

Trial registration: ClinicalTrials.gov NCT00307684 NCT01338818 NCT02675400 NCT04507204 NCT03481959.

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Conflict of interest statement

Kim Boesen: none known. Asger Sand Paludan‐Müller: none known. Peter C Gøtzsche: none known. Karsten Juhl Jørgensen: none known.

Figures

1
1
Flow diagram.
BfArM= Bundesinstitut für Arzneimittel und Medizinprodukte, FDA= US Food and Drug Administration, MEB= Medicines Evaluation Board, MHRA= Medicines and Healthcare products Regulatory Agency, TGA= Therapeutic Goods Administration, YODA= Yale University Open Data Access.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Funnel plot. Extended‐release methylphenidate versus placebo: ADHD symptoms (self‐rated).
4
4
Funnel plot of comparison: 1 Extended‐release methylphenidate versus placebo ‐ primary outcomes (short and medium term), outcome: 1.8 Serious adverse events.
5
5
Funnel plot of comparison: 2 Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short‐ and medium‐term), outcome: 2.4 ADHD symptoms (investigator‐rated) (short‐term).
1.1
1.1. Analysis
Comparison 1: Extended‐release methylphenidate versus placebo ‐ primary outcomes (short‐ and medium‐term), Outcome 1: Days missed at work/school/training (week 13)
1.2
1.2. Analysis
Comparison 1: Extended‐release methylphenidate versus placebo ‐ primary outcomes (short‐ and medium‐term), Outcome 2: Days missed at work/school/training (weeks 13‐26)
1.3
1.3. Analysis
Comparison 1: Extended‐release methylphenidate versus placebo ‐ primary outcomes (short‐ and medium‐term), Outcome 3: Days missed at work/school/training (weeks 26‐52)
1.4
1.4. Analysis
Comparison 1: Extended‐release methylphenidate versus placebo ‐ primary outcomes (short‐ and medium‐term), Outcome 4: ADHD symptoms (self‐rated) (short‐term)
1.5
1.5. Analysis
Comparison 1: Extended‐release methylphenidate versus placebo ‐ primary outcomes (short‐ and medium‐term), Outcome 5: ADHD symptoms (self‐rated) [subgroup MD] (short‐term)
1.6
1.6. Analysis
Comparison 1: Extended‐release methylphenidate versus placebo ‐ primary outcomes (short‐ and medium‐term), Outcome 6: ADHD symptoms (self‐rated) (medium‐term)
1.7
1.7. Analysis
Comparison 1: Extended‐release methylphenidate versus placebo ‐ primary outcomes (short‐ and medium‐term), Outcome 7: ADHD symptoms (self‐rated) [LMCF data] (medium‐term)
1.8
1.8. Analysis
Comparison 1: Extended‐release methylphenidate versus placebo ‐ primary outcomes (short‐ and medium‐term), Outcome 8: Serious adverse events
2.1
2.1. Analysis
Comparison 2: Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short and medium term), Outcome 1: Quality of life (self‐rated) (short‐term)
2.2
2.2. Analysis
Comparison 2: Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short and medium term), Outcome 2: Quality of life (self‐rated) [subgroup MD] (short‐term)
2.3
2.3. Analysis
Comparison 2: Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short and medium term), Outcome 3: Quality of life (self‐rated) (medium‐term)
2.4
2.4. Analysis
Comparison 2: Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short and medium term), Outcome 4: ADHD symptoms (investigator rated) (short‐term)
2.5
2.5. Analysis
Comparison 2: Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short and medium term), Outcome 5: ADHD symptoms (investigator‐rated) [subgroup MD] (short‐term)
2.6
2.6. Analysis
Comparison 2: Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short and medium term), Outcome 6: ADHD symptoms (investigator‐rated) (medium‐term)
2.7
2.7. Analysis
Comparison 2: Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short and medium term), Outcome 7: ADHD symptoms (investigator‐rated) [LMCF data] (medium‐term)
2.8
2.8. Analysis
Comparison 2: Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short and medium term), Outcome 8: ADHD symptoms (peer‐rated) (short‐term)
2.9
2.9. Analysis
Comparison 2: Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short and medium term), Outcome 9: Cardiovascular: pulse (beats per minute)
2.10
2.10. Analysis
Comparison 2: Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short and medium term), Outcome 10: Cardiovascular: systolic blood pressure
2.11
2.11. Analysis
Comparison 2: Extended‐release methylphenidate versus placebo ‐ secondary outcomes (short and medium term), Outcome 11: Cardiovascular: diastolic blood pressure
3.1
3.1. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 1: Dropout (overall)
3.2
3.2. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 2: Dropout (due to adverse events)
3.3
3.3. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 3: Adverse events (proportion experiencing any adverse event)
3.4
3.4. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 4: Psychiatric adverse events (proportion of participants)
3.5
3.5. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 5: Weight (change in kilograms)
3.6
3.6. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 6: Adverse event: decreased appetite
3.7
3.7. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 7: Adverse event: dry mouth
3.8
3.8. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 8: Adverse event: headache
3.9
3.9. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 9: Adverse event: palpitations
3.10
3.10. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 10: Adverse event: insomnia
3.11
3.11. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 11: Adverse event: sexual dysfunction
3.12
3.12. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 12: Adverse event: anxiety
3.13
3.13. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 13: Adverse event: depression
3.14
3.14. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 14: Adverse event: irritability
3.15
3.15. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 15: Adverse event: feeling jittery
3.16
3.16. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 16: Adverse event: agitation
3.17
3.17. Analysis
Comparison 3: Extended‐release methylphenidate versus placebo ‐ secondary outcomes: adverse events (short‐ and medium‐term), Outcome 17: Adverse event: aggression
4.1
4.1. Analysis
Comparison 4: Extended‐release methylphenidate versus placebo: subgroup and sensitivity analyses, Outcome 1: Overall dropout rate: psychiatric comorbidity (subgroup analysis)
4.2
4.2. Analysis
Comparison 4: Extended‐release methylphenidate versus placebo: subgroup and sensitivity analyses, Outcome 2: Overall dropout rate: 'enriched design' (subgroup analysis)
4.3
4.3. Analysis
Comparison 4: Extended‐release methylphenidate versus placebo: subgroup and sensitivity analyses, Outcome 3: Overall dropout rate: withdrawal effects (subgroup analysis)
4.4
4.4. Analysis
Comparison 4: Extended‐release methylphenidate versus placebo: subgroup and sensitivity analyses, Outcome 4: Overall dropout rate: funding (subgroup analysis)
4.5
4.5. Analysis
Comparison 4: Extended‐release methylphenidate versus placebo: subgroup and sensitivity analyses, Outcome 5: Proportion experiencing any adverse event: psychiatric comorbidity (subgroup analysis)
4.6
4.6. Analysis
Comparison 4: Extended‐release methylphenidate versus placebo: subgroup and sensitivity analyses, Outcome 6: Proportion experiencing any adverse event: withdrawal effects (subgroup analysis)
4.7
4.7. Analysis
Comparison 4: Extended‐release methylphenidate versus placebo: subgroup and sensitivity analyses, Outcome 7: Proportion experiencing any adverse event: funding (subgroup analysis)
4.8
4.8. Analysis
Comparison 4: Extended‐release methylphenidate versus placebo: subgroup and sensitivity analyses, Outcome 8: Proportion experiencing any adverse event: dropout rates (sensitivity analysis)
5.1
5.1. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 1: ADHD symptoms (self‐rated)
5.2
5.2. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 2: Serious adverse events
5.3
5.3. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 3: Adverse event: initial insomnia
5.4
5.4. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 4: Weight
5.5
5.5. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 5: ADHD symptoms (investigator‐rated)
5.6
5.6. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 6: Overall dropout
5.7
5.7. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 7: Adverse events (AE): proportion experiencing any AE
5.8
5.8. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 8: Adverse events (leading to dropout)
5.9
5.9. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 9: Adverse event: headache
5.10
5.10. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 10: Adverse event: decreased appetite
5.11
5.11. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 11: Adverse event: irritability
5.12
5.12. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 12: Adverse event: dry mouth
5.13
5.13. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 13: Adverse event: decreased libido
5.14
5.14. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 14: Adverse event: feeling jittery
5.15
5.15. Analysis
Comparison 5: Extended‐release methylphenidate versus atomoxetine, Outcome 15: Adverse events: palpitations
6.1
6.1. Analysis
Comparison 6: Extended‐release methylphenidate versus bupropion, Outcome 1: ADHD symptoms (self‐rated)
6.2
6.2. Analysis
Comparison 6: Extended‐release methylphenidate versus bupropion, Outcome 2: Overall dropout
6.3
6.3. Analysis
Comparison 6: Extended‐release methylphenidate versus bupropion, Outcome 3: Dropouts due to adverse events
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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    1. Ginsberg Y, Långström N, Larsson H, Lindefors N.Long-term treatment outcome in adult male prisoners with attention deficit/hyperactivity disorder: three-year naturalistic follow-up of a 52-week methylphenidate trial. Journal of Clinical Psychopharmacology 2015;35(5):535-43. [DOI: 10.1097/JCP.0000000000000395] [PMID: ] - DOI - PubMed
Goodman 2009 {published and unpublished data}
    1. Goodman DW, Starr HL, Ma YW, Rostain AL, Ascher S, Armstrong RB.Randomized, 6-week, placebo-controlled study of treatment for adult attention-deficit/hyperactivity disorder: individualized dosing of osmotic-release oral system (OROS) methylphenidate with a goal of symptom remission. Journal of Clinical Psychiatry 2017;78(1):105-14. [DOI: 10.4088/JCP.15m10348] [PMID: ] - DOI - PubMed
    1. K Boesen.Subject: Cochrane review [personal communication]. Email to: H Lynn Starr 18 April 2019.
    1. NCT00937040.Adult study/OROS methylphenidate hydrochloride (HCL) (OROS MPH) in adults with attention deficit hyperactivity disorder (ADHD) [A placebo controlled double-blind, parallel group, individualizing dosing study optimizing treatment of adults with attention deficit hyperactivity disorder to an effective response with OROS methylphenidate]. Available at clinicaltrials.gov/ct2/show/NCT00937040 (first received 10 July 2009). [accessed 1 December 2021]
    1. Yale University Open Data Access.Clinical Study Report Synopsis (CONCERTA-ATT-3014); 20 December 2010. Available at yoda.yale.edu/sites/default/files/nct00937040.pdf (accessed 1 December 2021).
    1. Yale University Open Data Access.NCT00937040 [A placebo controlled double-blind, parallel group, individualizing dosing study optimizing treatment of adults with attention deficit hyperactivity disorder to an effective response with OROS methylphenidate]. Available at yoda.yale.edu/nct00937040-placebo-controlled-double-blind-parallel-group... (accessed 1 December 2021).
Huss 2010 {published and unpublished data}
    1. Bundesinstitut für Arzneimittel und Medizinprodukte.Clinical Study Report Synopsis (CRIT124D2302); 7 November 2012. Available at portal.dimdi.de/data/ctr/O-4036816-2-0-E378D3-20190111110032.pdf (accessed 1 December 2021).
    1. Bundesinstitut für Arzneimittel und Medizinprodukte.Clinical Trial Report (CRIT24D2302E1); 5 February 2014. Available at portal.dimdi.de/data/ctr/O-4037228-2-0-A1764D-20140205152929.pdf (accessed 1 December 2021).
    1. Coles T, Coon C, DeMuro C, McLeod L, Gnanasakthy A.Psychometric evaluation of the Sheehan Disability Scale in adult patients with attention-deficit/hyperactivity disorder. Neuropsychiatric Disease and Treatment 2014;10:887-95. [DOI: 10.2147/NDT.S55220] [PMCID: PMC4038420] [PMID: ] - DOI - PMC - PubMed
    1. EUCTR 2010-021533-31.Clinical trial report (CRIT124D2302); 7 November 2012. Available at www.clinicaltrialsregister.eu/ctr-search/rest/download/result/attachment... (accessed 1 December 2021).
    1. EUCTR 2010-021533-31.Efficacy and safety study of methylphenidate hydrochloride modified release in adults with childhood-onset attention deficit/hyperactivity disorder (ADHD) [A 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the treatment of adult patients with childhood-onset ADHD]. Available at clinicaltrialsregister.eu/ctr-search/trial/2010-021533-31/DE (first received 9 November 2011). [accessed 1 December 2021]
Konstenius 2006 {published and unpublished data}
    1. ISRCTN81602628.Clinical trial of long acting methylphenidate in amphetamine addicts with attention deficit hyperactivity disorder (ADHD). Available at www.isrctn.com/ISRCTN81602628 (first received 21 April 2008). [accessed 1 December 2021]
    1. Konstenius M, Jayaram-Lindström N, Beck O, Franck J.Sustained release methylphenidate for the treatment of ADHD in amphetamine abusers: a pilot study. Drug and Alcohol Dependence 2010;108(1-2):130-3. [DOI: 10.1016/j.drugalcdep.2009.11.006] [PMID: ] - DOI - PubMed
Konstenius 2007 {published and unpublished data}
    1. EUCTR 2006­002249­35.Clinical trial of sustained release methylphenidate for attention­deficit­hyperactivity­disorder (ADHD) in adult criminal offenders with amphetamine addiction. Available at www.clinicaltrialsregister.eu/ctr-search/trial/2006-002249-35/SE (first received 9 June 2006). [accessed 1 December 2021]
    1. Franck J, Konstenius M, Jayaram-Lindstrom N, Philips B, Guterstam J.S-36-004. ADHD in drug addiction: a RCT on the feasibility of methylphenidate treatment in criminal amphetamine users. International Journal of Neuropsychopharmacology 2012;15(Suppl 1):41. [DOI: 10.1017/S1461145712000508] - DOI
    1. ISRCTN77940178.Clinical trial of sustained release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adult criminal offenders with amphetamine addiction. Available at www.isrctn.com/ISRCTN77940178 (first received 26 October 2007). [accessed 1 December 2021]
    1. K Boesen.Subject: Cochrane review [personal communication]. Email to: M Konstenius 19 February 2019.
    1. Konstenius M, Jayaram-Lindström N, Guterstam J, Beck O, Philips B, Franck J.Methylphenidate for attention deficit hyperactivity disorder and drug relapse in criminal offenders with substance dependence: a 24-week randomized placebo-controlled trial. Addiction 2014;109(3):440-9. Erratum in: Addition 2014; 109(9): 1571-2. [DOI: 10.1111/add.12369] [PMCID: PMC4226329] [PMID: ] - DOI - PMC - PubMed
Levin 1998a {published and unpublished data}
    1. Brooks DJ, Vosburg SK, Evans SK, Levin FR.Assessment of cognitive functioning of methadone-maintenance patients: impact of adult ADHD and current cocaine dependence. Journal of Addictive Diseases 2006;25(4):15-25. [DOI: 10.1300/j069v25n04_02] [PMID: 17088222 ] - DOI - PubMed
    1. Levin FR, Evans SM, Brooks DJ, Kalbag AS, Garawi F, Nunes EV.Treatment of methadone-maintained patients with adult ADHD: double-blind comparison of methylphenidate, bupropion and placebo. Drug and Alcohol Dependence 2006;81(2):137-48. [DOI: 10.1016/j.drugalcdep.2005.06.012] [PMID: ] - DOI - PubMed
    1. NCT00061087.Treatment of adult attention deficit hyperactivity disorder (ADHD) in methadone patients - 1 [Treatment of adult ADHD in methadone patients]. Available at clinicaltrials.gov/ct2/show/NCT00061087 (first received 22 May 2003). [accessed 1 December 2021]
    1. NIH RePORTER.5R01DA011444-05. Treatment of adult ADHD in methadone patients. reporter.nih.gov/project-details/6497805 (accessed 1 December 2021).
Levin 1998b {published and unpublished data}
    1. Aharonovich E, Garawi F, Bisaga A, Brooks D, Raby WN, Rubin E, et al.Concurrent cannabis use during treatment for comorbid ADHD and cocaine dependence: effects on outcome. American Journal of Drug and Alcohol Abuse 2006;32(4):629-35. [DOI: 10.1080/00952990600919005] [PMID: ] - DOI - PubMed
    1. Levin FR, Evans SM, Brooks DJ, Garawi F.Treatment of cocaine dependent treatment seekers with adult ADHD: double-blind comparison of methylphenidate and placebo. Drug and Alcohol Dependence 2007;87(1):20-9. [DOI: 10.1016/j.drugalcdep.2006.07.004] [PMID: ] - DOI - PubMed
    1. NCT00136734.Methylphenidate treatment for cocaine abuse and ADHD - 1 [Methylphenidate treatment for cocaine abuse and ADHD]. Available at clinicaltrials.gov/ct2/show/NCT00136734 (first received 29 August 2005). [accessed 1 December 2021]
    1. NIH RePORTER.1R01DA011755. Methylphenidate for treatment for cocaine abuse and ADHD. Available at reporter.nih.gov/search/PEPHwbrdG0WBUxKyva6Ozg/project-details/2596880 (accessed 1 December 2021).
Levin 2001 {published and unpublished data}
    1. Levin ED, Conners CK, Silva D, Canu W, March J.Effects of chronic nicotine and methylphenidate in adults with attention deficit/hyperactivity disorder. Experimental and Clinical Psychopharmacology 2001;9(1):83-90. [DOI: 10.1037/1064-1297.9.1.83] [PMID: ] - DOI - PubMed
Medori 2005 {published and unpublished data}
    1. Buitelaar JK, Casas M, Philipsen A, Kooij JJ, Ramos-Quiroga JA, Dejonckheere J, et al.Functional improvement and correlations with symptomatic improvement in adults with attention deficit hyperactivity disorder receiving long-acting methylphenidate. Psychological Medicine 2012;42(1):195-204. [DOI: 10.1017/S0033291711000845] [PMCID: PMC3226157] [PMID: ] - DOI - PMC - PubMed
    1. Buitelaar JK, Kooij JJ, Ramos-Quiroga JA, Dejonckheere J, Casas M, Van Oene JC, et al.Predictors of treatment outcome in adults with ADHD treated with OROS® methylphenidate. Progress in Neuro-Psychopharmacoloy and Biological Psychiatry 2011;35(2):554-60. [DOI: 10.1016/j.pnpbp.2010.12.016] - DOI - PubMed
    1. Buitelaar JK, Sobanski E, Stieglitz RD, Dejonckheere J, Waechter S, Schäuble B.Predictors of placebo response in adults with attention-deficit/hyperactivity disorder: data from 2 randomized trials of osmotic-release oral system methylphenidate. Journal of Clinical Psychiatry 2012;73(8):1097-102. [DOI: 10.4088/JCP.11m07528] [PMID: ] - DOI - PubMed
    1. Buitelaar JK, Trott GE, Hofecker M, Waechter S, Berwaerts J, Dejonkheere J, et al.Long-term efficacy and safety outcomes with OROS-MPH in adults with ADHD. International Journal of Neuropsychopharmacology 2012;15(1):1-13. [DOI: 10.1017/S1461145711001131] [PMCID: PMC3243903] [PMID: ] - DOI - PMC - PubMed
    1. Bundesinstitut für Arzneimittel und Medizinprodukte.Clinical Study Report Synopsis (42603A TT3004); 1 June 2009. Available at portal.dimdi.de/data/ctr/O-2154861-1-1-05F283-20190418181055.pdf (accessed 1 December 2021).
Retz 2008 {published and unpublished data}
    1. Bundesinstitut für Arzneimittel und Medizinprodukte.Clinical Study Report synopsis (2008-000942-29); 22 March 2010 (version 2). Available at portal.dimdi.de/data/ctr/O-2163890-1-0-179913-20170620143824.pdf (accessed August 2021).
    1. EUCTR 2008-000942­29.Quality assurance of methylphenidate administration in adults with ADHS [Qualitätssicherung der methylphendidatgabe bei erwachsenen mit ADHS]. Available at www.clinicaltrialsregister.eu/ctr-search/trial/2008-000942-29/DE (first received 17 November 2008). [accessed 1 December 2021]
    1. NCT00730249.Quality assurance of administering methylphenidate in adults with attention deficit hyperactivity disorder (ADHD) - QUMEA [Quality assurance of administering methylphenidate in adults with ADHD]. Available at clinicaltrials.gov/ct2/show/NCT00730249 (first received 8 August 2008). [accessed 1 December 2021]
    1. Retz W, Rösler M, Ose C, Scherag A, Alm B, Philipsen A, et al.Multiscale assessment of treatment efficacy in adults with ADHD: a randomized placebo-controlled, multi-centre study with extended-release methylphenidate. World Journal of Biological Psychiatry 2012;13(1):48-59. [DOI: 10.3109/15622975.2010.540257] [PMCID: PMC3279134] [PMID: ] - DOI - PMC - PubMed
Rösler 2004 {published and unpublished data}
    1. Bundesinstitut für Arzneimittel und Medizinprodukte.Public Assessment Report, Medikinet. portal.dimdi.de/amguifree/am/docoutput/additionalDocDownload.xhtml?dntOb... (accessed prior to 1 August 2021).
    1. Bundesinstitut für Arzneimittel und Medizinprodukte.Public Assessment Report [Öffentlicher bewertungsbericht zur änderungsanzeige vom 14.01.2011. Medikinet adult; 18 July 2011]. Available at portal.dimdi.de/amispb/doc/2011/07/25/2163890/OBFMBD5B836E01CC4AAA.rtf (accessed 1 December 2021).
    1. NCT00619840.Placebo-controlled multi-centre double-blind trial for adults with extended-release methylphenidate for ADHD (EMMA) [Placebo-controlled multi-centre double-blind trial for adults with extended-release methylphenidate for ADHD]. Available at clinicaltrials.gov/ct2/show/NCT00619840 (first received 21 February 2008). [accessed 1 December 2021]
    1. Rösler M, Fischer R, Ammer R, Ose C, Retz W, on behalf of the Study Group.Erratum to: European Archives of Psychiatry and Clinical Neuroscience 2009; 259:120–9. DOI 10.1007/s00406-008-0845-4. European Archives of Psychiatry and Clinical Neuroscience 2009;259:368. [DOI: 10.1007/s00406-009-0005-5] - DOI - PubMed
    1. Rösler M, Fischer R, Ammer R, Ose C, Retz W.A randomised, placebo-controlled, 24-week, study of low-dose extended-release methylphenidate in adults with attention-deficit/hyperactivity disorder. European Archives of Psychiatry and Clinical Neuroscience 2009;259(2):120-9. Erratum in: European Archives of Psychiatry and Clinical Neuroscience 2009;259(6):368. [DOI: 10.1007/s00406-008-0845-4] [PMID: ] - DOI - PubMed
Spencer 2003a {published and unpublished data}
    1. Adler LA, Spencer T, McGough JJ, Jiang H, Muniz R.Long-term effectiveness and safety of dexmethylphenidate extended-release capsules in adult ADHD. Journal of Attention Disorders 2009;12(5):449-59. [DOI: 10.1177/1087054708320397] [PMID: ] - DOI - PubMed
    1. Adler LA, Spencer T, Wang J, Pestreich L, Muniz R.P03.006. Efficacy and safety of once-daily extended-release dexmethylphenidate 30 and 40 mg in adults with ADHD: a double-blind, fixed-dose, placebo-controlled, randomized study. International Journal of Neuropsychopharmacology 2006;9(Suppl 1):S229. [DOI: 10.1017/S1461145706007292] - DOI
    1. Novartis.Clinical Study Report Synopsis (CRIT124E2302); updated 9 September 2005. Available at www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=1623 (accessed 1 December 2021).
    1. Spencer TJ, Adler LA, McGough JJ, Muniz R, Jiang H, Pestreich L, et al.Efficacy and safety of dexmethylphenidate extended-release capsules in adults with attention-deficit/hyperactivity disorder. Biological Psychiatry 2007;61(12):1380-7. [DOI: 10.1016/j.biopsych.2006.07.032] [PMID: ] - DOI - PubMed
    1. US Food and Drug Administration.Drug Approval Package: Focalin XR (dexmethylphenidate hydrochloride) extended release capsules; 2 July 2007. Available at www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021802s000TOC.cfm (accessed 1 December 2021).
Takahashi 2011 {published and unpublished data}
    1. NCT01323192.An efficacy and safety study for JNS001 in adults with attention­deficit hyperactivity disorder [A double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of JNS001 in adults with attention-deficit/hyperactivity disorder at doses of 18 mg, 36 mg, 54 mg, or 72 mg per day]. Available at clinicaltrials.gov/ct2/show/NCT01323192 (first received 25 March 2011). [accessed 1 December 2021]
    1. Takahashi N, Koh T, Tominaga Y, Saito Y, Kashimoto Y, Matsumura T.A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of osmotic-controlled release oral delivery system methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in Japan. World Journal of Biological Psychiatry 2014;15(6):488-98. [DOI: 10.3109/15622975.2013.868925] [PMID: ] - DOI - PubMed
    1. Yale University Open Data Access.Clinical Study Report Synopsis (JNS001-JPN-A01); 20 November 2012. Available at yoda.yale.edu/sites/default/files/nct01323192.pdf (accessed 1 December 2021).
    1. Yale University Open Data Access.NCT001323192 [A double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of JNS001 in adults with attention-deficit/hyperactivity disorder at doses of 18 mg, 36 mg, 54 mg, or 72 mg per day]. yoda.yale.edu/nct01323192-double-blind-placebo-controlled-parallel-group... (accessed 1 December 2021).
Weisler 2009 {published and unpublished data}
    1. K Boesen.Subject: Cochrane review [personal communication]. Email to: E Daly 19 February 2019.
    1. NCT00880217.A study to evaluate 3 different doses of JNJ­31001074 in the treatment of adults with attention­deficit/hyperactivity disorder (ADHD) [A randomized, double-blind, placebo- and active-controlled, parallel-group, multicenter study of 3 dosages of JNJ-31001074 in the treatment of adult subjects with attention-deficit/hyperactivity disorder]. Available at clinicaltrials.gov/ct2/show/NCT00880217 (first received 13 April 2009). [accessed 1 December 2021]
    1. Pandina G, Daly E, Gassmann-Mayer C, Cooper K.Exploratory analyses of efficacy by sex and age of histamine3 (h3) receptor antagonist (bavisant) for the treatment of adults with attention deficit hyperactivity disorder. In: 67th Annual Convention of the Society of Biological Psychiatry; 2012 May 3-5; Philadelphia (PA). Philadelphia (PA), 2012. [Poster #203]
    1. Weisler RH, Pandina GJ, Daly EJ, Cooper K, Gassmann-Mayer C, 31001074-ATT2001 Study Investigators.Randomized clinical study of a histamine H3 receptor antagonist for the treatment of adults with attention-deficit hyperactivity disorder. CNS Drugs 2012;26(5):421-34. [DOI: 10.2165/11631990-000000000-00000] [PMID: ] - DOI - PubMed
Weiss 2014 {published and unpublished data}
    1. Health Canada.Product Monograph: Foquest® Submission Control No: 214860; 1 March 2019. Available at pdf.hres.ca/dpd_pm/00049955.PDF (accessed 1 December 2021).
    1. NCT02139124.The efficacy and safety of PRC­063 in adult ADHD patients [A phase III, randomized, double-blind, placebo-controlled, parallel-arm, multi-center study measuring the efficacy and safety of PRC-063 in adult ADHD patients]. Available at clinicaltrials.gov/ct2/show/study/NCT02139124 (first received 15 May 2014). [accessed 1 December 2021]
    1. Quinn D, Weiss MD, Donnelly G, Reiz J.Effect of PRC-063 on executive functioning in adults with ADHD treated in a randomized, double-blind, placebo-controlled, multi-center study with a six-month open label extension [poster]. In: 66th Annual Meeting of the Canadian Psychiatric Association; 2016 Sep 22-24; Toronto (ON). 2016.
    1. US Food and Drug Administration.Drug Approval Package: Adhansia XR; 7 February 2019. Available at www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212038Orig1s000TOC.cfm (accessed 1 December 2021).
    1. Weiss MD, Childress AC, Donnelly GA.Efficacy and safety of PRC-063, extended-release multilayer methylphenidate in adults with ADHD including 6-month open-label extension. Journal of Attention Disorders 2021;25(10):1417-28. [DOI: 10.1177/1087054719896853] [PMCID: PMC8273537] [PMID: ] - DOI - PMC - PubMed
Winhusen 2005 {published and unpublished data}
    1. Berlin I, Hu MC, Covey LS, Winhusen T.Attention-deficit/hyperactivity disorder (ADHD) symptoms, craving to smoke, and tobacco withdrawal symptoms in adult smokers with ADHD. Drug and Alcohol Dependence 2012;124(3):268-73. [DOI: 10.1016/j.drugalcdep.2012.01.019] [NIHMSID: NIHMS444432] [PMCID: PMC3605750] [PMID: ] - DOI - PMC - PubMed
    1. Boesen K.Cochrane review [personal communication]. Email to : T Winhusen 18 February 2019.
    1. Covey LS, Hu MC, Green CA, Brigham G, Hurt RD, Adler L, et al.An exploration of site effects in a multisite trial of OROS-methylphenidate for smokers with attention deficit/hyperactivity disorder. American Journal of Drug and Alcohol Abuse 2011;37(5):392-9. [DOI: 10.3109/00952990.2011.596979] [PMCID: PMC3510007] [PMID: ] - DOI - PMC - PubMed
    1. Covey LS, Hu MC, Weissman J, Croghan I, Adler L, Winhusen T.Divergence by ADHD subtype in smoking cessation response to OROS-methylphenidate. Nicotine & Tobacco Research 2011;13(10):1003-8. [DOI: 10.1093/ntr/ntr087] [PMCID: PMC3179666] [PMID: ] - DOI - PMC - PubMed
    1. Covey LS, Hu MC, Winhusen T, Lima J, Berlin I, Nunes E.Anxiety and depressed mood decline following smoking abstinence in adult smokers with attention deficit hyperactivity disorder. Journal of Substance Abuse Treatment 2015;59:104-8. [DOI: 10.1016/j.jsat.2015.07.004] [NIHMSID: NIHMS709235] [PMCID: PMC4661105] [PMID: ] - DOI - PMC - PubMed

References to studies excluded from this review

Adler 2011 {published data only}
    1. Adler LA, Orman C, Starr HL, Silber S, Palumbo J, Cooper K, et al.Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study. Journal of Clinical Psychopharmacology 2011;31(1):108-14. [DOI: 10.1097/JCP.0b013e318203ea0a] [PMID: ] - DOI - PubMed
Ang 2015 {published data only}
    1. Ang A, Hillhouse M, Jenkins J, Reed S, Ling W.Methylphenidate for methamphetamine use disorders in participants with and without ADHD. Drug and Alcohol Dependence 2015;156:e7. [DOI: 10.1016/j.drugalcdep.2015.07.938] - DOI
Biehl 2016 {published data only}
    1. Biehl SC, Merz CJ, Dresler T, Heupel J, Reichert S, Jacob CP, et al.Increase or decrease of fMRI activity in adult attention deficit/hyperactivity disorder: does it depend on task difficulty? International Journal of Neuropsychopharmacology 2016;19(10):pyw049. [DOI: 10.1093/ijnp/pyw049] [PMCID: PMC5091824] [PMID: ] - DOI - PMC - PubMed
Bink 2014 {published data only}
    1. Bink M, Van Nieuwenhuizen C, Popma A, Bongers IL, Van Boxtel GJ.Neurocognitive effects of neurofeedback in adolescents with ADHD: a randomized controlled trial. Journal of Clinical Psychiatry 2014;75(5):535-42. [DOI: 10.4088/JCP.13m08590] [PMID: ] - DOI - PubMed
Bouziane 2019 {published data only}
    1. Bouziane C, Filatova OG, Schrantee A, Caan MW, Vos FM, Reneman L.White matter by diffusion MRI following methylphenidate treatment: a randomized control trial in males with attention-deficit/hyperactivity disorder. Radiology 2019;293(1):186-92. [DOI: 10.1148/radiol.2019182528] [PMID: ] - DOI - PubMed
Buitelaar 2009 {published data only}
    1. Buitelaar JK, Ramos-Quiroga JA, Casas M, Kooij JJ, Niemelä A, Konofal E, et al.Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. Neuropsychiatric Disease and Treatment 2009;5:457-66. [DOI: 10.2147/ndt.s6873] [PMCID: PMC2747385] [PMID: ] - DOI - PMC - PubMed
EUCTR 2005‐004037‐18 {published data only}
    1. EUCTR 2005-004037-18.An open label, multicentre study to evaluate the long term safety of prolonged release (PR) OROS methylphenidate (18, 36, 54, 72 and 90 mg/day) in adults with attention deficit/hyperactivity disorder - Lamda extension. www.clinicaltrialsregister.eu/ctr-search/trial/2005-004037-18/DE (first received 1 December 2005). [accessed September 2021]
EUCTR 2008‐006242‐26 {published data only}
    1. EUCTR 2008-006242-26/DE.Genetic modulation of functional brain activity of attention-deficit/hyperactivity disorder-related working memory processes. www.clinicaltrialsregister.eu/ctr-search/trial/2008-006242-26/DE (first received 7 August 2009).
EUCTR 2010‐023654‐37 {published data only}
    1. EUCTR 2010-023654-37/NL.Ritalin and the developing brain [Effects of methylphenidate on the development of the dopaminergic system in the brain]. www.clinicaltrialsregister.eu/ctr-search/trial/2010-023654-37/NL (first received 1 November 2010).
EUCTR 2011‐000210‐19 {published data only}
    1. EUCTR 2011-000210-19/DE.Six-month open label extension to an efficacy and safety study of Ritalin LA in the treatment of adult patients with childhood-onset ADHD [A 6-month, open-label extension to a 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the treatment of adult patients with childhood-onset ADHD]. www.clinicaltrialsregister.eu/ctr-search/trial/2011-000210-19/DE (first received 7 April 2011).
EUCTR 2012‐000517‐37 {published data only}
    1. EUCTR 2012-000517-37/GB.Clinical trial of Concerta for the treatment of ADHD in adult offenders [A pilot study of Concerta XL in adult offenders with ADHD]. www.clinicaltrialsregister.eu/ctr-search/trial/2012-000517-37/GB (first received 31 October 2012).
EUCTR 2014‐001488‐11 {published data only}
    1. EUCTR 2014-001488-11/SE.Effects of expectations, medication and placebo during the Quantified Behavior Test in patients with untreated ADHD and substance use disorder [Effekten av förväntning, läkemedel och placebo på objektiv och självskattad prestation vid QbTest hos patienter med obehandlad ADHD och substanssyndrom] [Effects of expectations, medication and placebo on objective and self-rated performance during the Quantified Behavior Test in terms of the ADHD core signs hyperactivity, inattention and impulsivity in patients with untreated ADHD and substance use disorder [Effekten av förväntning, aktivt läkemedel och placebo på objektiv och självskattad prestation vid QbTest avseende ADHD-kärnsymtomen hyperaktivitet, ouppmärksamhet och impulsivitet hos patienter med obehandlad ADHD och substanssyndrom]]. www.clinicaltrialsregister.eu/ctr-search/trial/2014-001488-11/SE (first received 16 December 2014).
EUCTR 2017‐000368‐14 {published data only}
    1. EUCTR 2017-000368-14/SE.A clinical trial of methylphenidate and lisdexamphetamine treatment in adults with attention-deficit hyperactivity disorder [En jämförande studie av metylfenidat och lisdexamfetamine hos vuxna personer med ADHD] [A head-to-head randomized clinical trial of methylphenidate and lisdexamphetamine treatment for executive functions and global functioning in adults with ADHD [En jämförande randomiserad klinisk prövning med metylfenidat och lisdexamfetamine behandling med avseende på exekutiva funktioner och global funktionsnivå hos vuxna personer med ADHD]]. www.clinicaltrialsregister.eu/ctr-search/trial/2017-000368-14/SE (first received 30 March 2017).
Geissler 2020 {published data only}
    1. Geissler JM, Vloet TD, Strom N, Jaite C, Graf E, Kappel V, et al.Does helping mothers in multigenerational ADHD also help children in the long run? 2-year follow-up from baseline of the AIMAC randomized controlled multicentre trial. European Child & Adolescent Psychiatry 2020;29(10):1425-39. [DOI: 10.1007/s00787-019-01451-0] [PMID: ] - DOI - PubMed
Häge 2018 {published data only}
    1. Häge A, Alm B, Banaschewski T, Becker K, Colla M, Freitag C, et al.Does the efficacy of parent-child training depend on maternal symptom improvement? Results from a randomized controlled trial on children and mothers both affected by attention-deficit/hyperactivity disorder (ADHD). European Child & Adolescent Psychiatry 2018;27(8):1011-21. [DOI: 10.1007/s00787-018-1109-0] [PMID: ] - DOI - PubMed
Imhof 2009 {published data only}
    1. Imhof L, Nyerod HJ, Filipe HJ, Dejonckheere J, Wachter S, Schauble B, et al.P.1.i.034 Efficacy outcomes during longterm prolonged-release methylphenidate treatment of adults with ADHD. European Neuropsychopharmacology 2009;19(Suppl 3):S353-4. [DOI: 10.1016/S0924-977X(09)70537-1] - DOI
ISRCTN52392534 {published data only}ISRCTN52392534
    1. ISRCTN52392534.The Continuous Performance Test (CPT) study: OROS-methylphenidate efficacy on objective measures [Efficacy of OROS-methylphenidate on specific executive functioning deficits in adults with Attention deficit hyperactivity disorder (ADHD)]. www.isrctn.com/ISRCTN52392534 (first received 18 June 2013).
ISRCTN77828247 {published data only}ISRCTN77828247
    1. ISRCTN77828247.Biphentin effects in attention deficit hyperactivity disorder (ADHD) drivers [Biphentineffects in attention deficit hyperactivity disorder (ADHD) drivers: a randomised, placebo controlled, crossover study of multilayer-release (MLR) methylphenidate on driving performance in adult ADHD patients]. www.isrctn.com/ISRCTN77828247 (first received 13 July 2009).
Jans 2013 {published data only}
    1. Jans T, Graf E, Jacob C, Zwanzger U, Gross-Lesch S, Matthies S, et al.A randomized controlled multicentre trial on the treatment for ADHD in mothers and children: enrolment and basic characteristics of the study sample. ADHD Attention Deficit and Hyperactivity Disorders 2013;5(1):29-40. [DOI: 10.1007/s12402-012-0092-4] [PMID: ] - DOI - PubMed
Levin 2002 {published data only}
    1. Levin FR, Evans SM, McDowell DM, Brooks DJ, Nunes E.Bupropion treatment for cocaine abuse and adult attention-deficit/hyperactivity disorder. Journal of Addictive Diseases 2002;21(2):1-16. [DOI: 10.1300/J069v21n02_01] [PMID: ] - DOI - PubMed
Marchant 2010 {published data only}
    1. Marchant BK, Reimherr FW, Halls C, Williams ED, Strong RE.OROS methylphenidate in the treatment of adults with ADHD: a 6-month, open-label, follow-up study. Annals of Clinical Psychiatry 2010;22(3):196-204. [PMID: ] - PubMed
NCT00307684 {published data only}
    1. NCT00307684.Open label, multicentre extension study of protocol 42603ATT3002 to evaluate safety of prolonged release OROS methlyphenidate in adults with attention deficit hyperactivity disorder (ADHD) [An open international multicentre long-term follow up study to evaluate safety of prolonged release OROS methlyphenidate in adults with attention deficit hyperactivity disorder]. www.clinicaltrials.gov/ct2/show/NCT00307684 (first received 28 March 2006). [accessed September 2021]
NCT01338818 {published data only}
    1. NCT01338818.Open-label extension evaluating methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder [A 6-month, open-label extension to a 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of methylphenidate hydrochloride extended release in the treatment of adult patients with childhood-onset ADHD]. www.clinicaltrials.gov/ct2/show/NCT01338818 (first received 20 April 2011).
NCT02675400 {published data only}
    1. NCT02675400.Treatments for fathers with ADHD and their at-risk children (Fathers Too) [Treatments for fathers with attention deficit/hyperactivity disorder (ADHD) and their at-risk children (Fathers Too)]. www.clinicaltrials.gov/ct2/show/NCT02675400 (first received 5 February 2016).
NCT04507204 {published data only}
    1. NCT04507204.Real-world evidence of duration of effect of adhansia XR (extended-release) for treatment of attention-deficit/hyperactivity disorder (ADHD) (RE-DAX) [Real-world evidence of duration of adhansia XR for treatment of ADHD (RE-DAX): an open-label pragmatic study to assess the real-world effectiveness of adhansia XR in treatment of adult and adolescent patients with ADHD in the United States]. www.clinicaltrials.gov/ct2/show/NCT04507204 (first received 11 August 2020).
Olsen 2012 {published data only}
    1. Olsen JL, Reimherr FW, Marchant BK, Wender PH, Robison RJ.The effect of personality disorder symptoms on response to treatment with methylphenidate transdermal system in adults with attention-deficit/hyperactivity disorder. Primary Care Companion for CNS Disorders 2012;14(5):PCC.12m01344. [DOI: 10.4088/PCC.12m01344] [PMCID: PMC3583767] [PMID: ] - DOI - PMC - PubMed
Reimherr 2010 {published data only}
    1. Reimherr FW, Marchant BK, Williams ED, Strong RE, Halls C, Soni P.Personality disorders in ADHD part 3: personality disorder, social adjustment, and their relation to dimensions of adult ADHD. Annals of Clinical Psychiatry 2010;22(2):103-12. [PMID: ] - PubMed
Reimherr 2013 {published data only}
    1. Reimherr FW, Marchant BK, Olsen JL, Wender PH, Robison RJ.Oppositional defiant disorder in adults with ADHD. Journal of Attention Disorders 2013;17(2):102-13. [DOI: 10.1177/1087054711425774] [PMID: ] - DOI - PubMed
Reimherr 2015 {published data only}
    1. Reimherr FW, Marchant BK, Gift TE, Steans TA, Wender PH.Types of adult attention-deficit hyperactivity disorder (ADHD): baseline characteristics, initial response, and long-term response to treatment with methylphenidate. Attention Deficit and Hyperactivity Disorders 2015;7(2):115-28. [DOI: 10.1007/s12402-015-0176-z] [PMID: ] - DOI - PubMed
Schaeuble 2010 {published data only}
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Schrantee 2016a {published data only}
    1. Boesen K.Methylphenidate trial [personal communication]. Email to: L Reneman 3 January 2018.
    1. Schrantee A, Tamminga HG, Bouziane C, Bottelier MA, Bron EE, Klein S, et al.474. A randomized clinical trial on the age-dependent effects of methylphenidate on the human dopaminergic system. Biological Psychiatry 2016;79(Suppl 9):S157. [URL: Available at www.sobp.org/journal] - PMC - PubMed
Schrantee 2016b {published data only}
    1. Boesen K.Methylphenidate trial [personal communication]. Email to: L Reneman 3 January 2018.
    1. Schrantee A, Tamminga HG, Bouziane C, Bottelier MA, Bron EE, Mutsaerts H-JM, et al.Age-dependent effects of methylphenidate on the human dopaminergic system in young vs adult patients with attention-deficit/hyperactivity disorder: a randomized clinical trial. JAMA Psychiatry 2016;73(9):955-62. [DOI: 10.1001/jamapsychiatry.2016.1572] [PMCID: PMC5267166] [PMID: ] - DOI - PMC - PubMed
Surman 2019 {published data only}
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Walhovd 2020 {published data only}
    1. Walhovd KB, Amlien I, Schrantee A, Rohani DA, Groote I, Bjørnerud A, et al.Methylphenidate effects on cortical thickness in children and adults with attention-deficit/hyperactivity disorder: a randomized clinical trial. AJNR: American Journal of Neuroradiology 2020;41(5):758‐65. [DOI: 10.3174/ajnr.A6560] [PMCID: PMC7228175 (available on 2021-05-01)] [PMID: ] - DOI - PMC - PubMed
Wender 1998 {published data only}
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Williams 2010 {published data only}
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References to studies awaiting assessment

Perry 2002 {published data only}
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Spencer 2003b {published data only}
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Spencer 2004 {published data only}
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Wender 2002 {published data only}
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Wender 2003a {published data only}
    1. Wender PH, Szajkowski L, Marchant B, Reimherr FW, Sanford E, Eden J.A long-term study of methylphenidate in the treatment of ADHD in adults. In: 156th Annual Meeting of the American Psychiatric Association; 2003 May 17-22; San Francisco (CA). 2003:NR708. [CENTRAL: CN-00592892]
Wender 2003b {published data only}
    1. Wender PH, Reimherr FW, Marchant B, Sanford E, Czajkowski L.A long-term trial of methylphenidate in the treatment of ADHD in adults. In: 156th Annual Meeting of the American Psychiatric Association; 2003 May 17-22 San Francisco (CA). 2003:NR709. [CENTRAL: CN-00592894]
Zhong 2019 {published data only}
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References to ongoing studies

Methacan 2017 {published data only}
    1. EUCTR 2017-000386-77.Effectiveness of extended release methylphenidate in reducing cannabis use in young cannabis­-dependent patients with attention deficit hyperactivity disorder (ADHD). Available at www.clinicaltrialsregister.eu/ctr-search/trial/2017-000386-77/FR (first received 22 January 2018). [accessed 1 December 2021]
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References to other published versions of this review

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