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Meta-Analysis
. 2017 Aug 9;8(8):CD008559.
doi: 10.1002/14651858.CD008559.pub3.

Atypical antipsychotics for disruptive behaviour disorders in children and youths

Jik H Loy  1 , Sally N Merry, Sarah E Hetrick, Karolina Stasiak
Affiliations
Meta-Analysis

Atypical antipsychotics for disruptive behaviour disorders in children and youths

Jik H Loy et al. Cochrane Database Syst Rev. .

Abstract

Background: This is an update of the original Cochrane Review, last published in 2012 (Loy 2012). Children and youths with disruptive behaviour disorders may present to health services, where they may be treated with atypical antipsychotics. There is increasing usage of atypical antipsychotics in the treatment of disruptive behaviour disorders.

Objectives: To evaluate the effect and safety of atypical antipsychotics, compared to placebo, for treating disruptive behaviour disorders in children and youths. The aim was to evaluate each drug separately rather than the class effect, on the grounds that each atypical antipsychotic has different pharmacologic binding profile (Stahl 2013) and that this is clinically more useful.

Search methods: In January 2017, we searched CENTRAL, MEDLINE, Embase, five other databases and two trials registers.

Selection criteria: Randomised controlled trials of atypical antipsychotics versus placebo in children and youths aged up to and including 18 years, with a diagnosis of disruptive behaviour disorders, including comorbid ADHD. The primary outcomes were aggression, conduct problems and adverse events (i.e. weight gain/changes and metabolic parameters). The secondary outcomes were general functioning, noncompliance, other adverse events, social functioning, family functioning, parent satisfaction and school functioning.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. Two review authors (JL and KS) independently collected, evaluated and extracted data. We used the GRADE approach to assess the quality of the evidence. We performed meta-analyses for each of our primary outcomes, except for metabolic parameters, due to inadequate outcome data.

Main results: We included 10 trials (spanning 2000 to 2014), involving a total of 896 children and youths aged five to 18 years. Bar two trials, all came from an outpatient setting. Eight trials assessed risperidone, one assessed quetiapine and one assessed ziprasidone. Nine trials assessed acute efficacy (over four to 10 weeks); one of which combined treatment with stimulant medication and parent training. One trial was a six-month maintenance trial assessing symptom recurrence.The quality of the evidence ranged from low to moderate. Nine studies had some degree of pharmaceutical support/funding. Primary outcomesUsing the mean difference (MD), we combined data from three studies (238 participants) in a meta-analysis of aggression, as assessed using the Aberrant Behaviour Checklist (ABC) ‒ Irritability subscale. We found that youths treated with risperidone show reduced aggression compared to youths treated with placebo (MD -6.49, 95% confidence interval (CI) -8.79 to -4.19; low-quality evidence). Using the standardised mean difference (SMD), we pooled data from two risperidone trials (190 participants), which used different scales: the Overt Aggression Scale ‒ Modified (OAS-M) Scale and the Antisocial Behaviour Scale (ABS); as the ABS had two subscales that could not be combined (reactive and proactive aggression), we performed two separate analyses. When we combined the ABS Reactive subscale and the OAS-M, the SMD was -1.30 in favour of risperidone (95% CI -2.21 to -0.40, moderate-quality evidence). When we combined the ABS Proactive subscale and OAS-M, the SMD was -1.12 (95% CI -2.30 to 0.06, moderate-quality evidence), suggesting uncertainty about the estimate of effect, as the confidence intervals overlapped the null value. In summary, there was some evidence that aggression could be reduced by risperidone. Data were lacking on other atypical antipsychotics, like quetiapine and ziprasidone, with regard to their effects on aggression.We pooled data from two risperidone trials (225 participants) in a meta-analysis of conduct problems, as assessed using the Nisonger Child Behaviour Rating Form ‒ Conduct Problem subscale (NCBRF-CP). This yielded a final mean score that was 8.61 points lower in the risperidone group compared to the placebo group (95% CI -11.49 to -5.74; moderate-quality evidence).We investigated the effect on weight by performing two meta-analyses. We wanted to distinguish between the effects of antipsychotic medication only and the combined effect with stimulants, since the latter can have a counteracting effect on weight gain due to appetite suppression. Pooling two trials with risperidone only (138 participants), we found that participants on risperidone gained 2.37 kilograms (kg) more (95% CI 0.26 to 4.49; moderate-quality evidence) than those on placebo. When we added a trial where all participants received a combination of risperidone and stimulants, we found that those on the combined treatment gained 2.14 kg more (95% CI 1.04 to 3.23; 3 studies; 305 participants; low-quality evidence) than those on placebo. Secondary outcomesOut of the 10 included trials, three examined general functioning, social functioning and parent satisfaction. No trials examined family or school functioning. Data on non-compliance/attrition rate and other adverse events were available from all 10 trials.

Authors' conclusions: There is some evidence that in the short term risperidone may reduce aggression and conduct problems in children and youths with disruptive behaviour disorders There is also evidence that this intervention is associated with significant weight gain.For aggression, the difference in scores of 6.49 points on the ABC ‒ Irritability subscale (range 0 to 45) may be clinically significant. It is challenging to interpret the clinical significance of the differential findings on two different ABS subscales as it may be difficult to distinguish between reactive and proactive aggression in clinical practice. For conduct problems, the difference in scores of 8.61 points on the NCBRF-CP (range 0 to 48) is likely to be clinically significant. Weight gain remains a concern.Caution is required in interpreting the results due to the limitations of current evidence and the small number of high-quality trials. There is a lack of evidence to support the use of quetiapine, ziprasidone or any other atypical antipsychotic for disruptive behaviour disorders in children and youths and no evidence for children under five years of age. It is uncertain to what degree the efficacy found in clinical trials will translate into real-life clinical practice. Given the effectiveness of parent-training interventions in the management of these disorders, and the somewhat equivocal evidence on the efficacy of medication, it is important not to use medication alone. This is consistent with current clinical guidelines.

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Conflict of interest statement

Jik H Loy is a co‐investigator on a Health Research Grant (grant number 13/331) to evaluate the effectiveness of a modular, psychosocial intervention — Modular Approach to Treatment of Children ‒ Anxiety, Depression,Trauma and Conduct (MATCH‐ADTC) — in secondary mental health services for children and adolescents. It is unrelated to this review.

Sally N Merry (SM) is a board member for the International Society for Research in Internet Interventions, which is an unpaid position. SM is a consultant on a psychosocial intervention being carried out as an addition to a trial on antidepressant medication being carried out at Cambridge University. SM declares that both positions are unrelated to this review. SM is a co‐developer of SPARX — an online cognitive behavioural therapy for adolescents with depression. The intellectual property belongs to Uniservices Ltd Auckland (the commercial arm of the University of Auckland) and if SPARX were commercialised, SM stands to gain financially. SM is a Principal Investigator on the Health Research Grant (grant number 13/331) to evaluate the effectiveness of a modular psychosocial intervention (MATCH‐ADTC) in secondary mental health services for children and adolescents. It is unrelated to this review. SM is a co‐investigator with Karolina Stasiak on a project funded by the Ministry of Business, Innovation and Employment (MBIE) to develop and trial an e‐health platform to deliver interventions for common mental health problems in adolescence. SM declares this project is not related to this review.

Sarah E Hetrick's (SEH) institution receives funds from the Federal Government of Australia and the Colonial Foundation for this review update. SH received a Clinical Training Fellowship from the Australian National Health and Medical Research Council, which supports research focused on implementation of evidence for youth depression. She is a named investigator on several randomised controlled trials (RCTs) funded by the Australian National Health and Medical Research Council, but none are related to this review.

Karolina Stasiak (KS) is Senior Research Fellow at the Department of Psychological Medicine at the University of Auckland, where is she involved in applied research in the area of child, youth and family mental health. KS is a co‐developer of SPARX ‐ an online cognitive behavioural therapy for adolescents with depression. The intellectual property belongs to Uniservices Ltd Auckland (the commercial arm of the University of Auckland) and if SPARX were commercialised, KS stands to gain financially. In addition, KS is a co‐investigator with Sally Merry on a project funded by the MBIE to develop and trial an e‐health platform to deliver interventions for common mental health problems in adolescence. KS is also a co‐investigator in the Health Research Grant (grant number 13/331), to evaluate the effectiveness of a modular psychosocial intervention (MATCH‐ADTC) in secondary mental health services for children and adolescents, and a co‐investigator on a project funded by the Oakley Mental Health Foundation & Starship Foundation, to develop and evaluate an e‐health intervention to support psychological needs of children living with long‐term physical illness. KS is a co‐principal investigator on an open trial, funded by the Oakley Mental Health Foundation, to test the feasibility of an internet‐based cognitive behavioural therapy self‐help resource for children and adolescents in the aftermath of Christchurch earthquakes. KS has also worked on two projects funded by the Counties Manukau District Health Board to evaluate an intensive parenting programme for parents experiencing significant parenting problems with infants and young children. KS declares that none of these projects are related to this review. In the interests of transparency, KS declares travel grants from the Auckland Medical Research Foundation, to present a paper at the fifth European Conference on Positive Psychology; and the Maurice Phyllis Paykel Trust, to present a paper at the fifth European Conference on Positive Psychology.

Figures

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1
study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Aman 2002 {published data only}
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Reyes 2006a {published data only}
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Snyder 2002 {published data only}
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TOSCA study {published data only (unpublished sought but not used)}
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    1. Arnold LE, Gadow KD, Farmer CA, Findling RL, Bukstein O, Molina BS, et al. Comorbid anxiety and social avoidance in treatment of severe childhood aggression: response to adding risperidone to stimulant and parent training; mediation of disruptive symptom response. Journal of Child and Adolescent Psychopharmacology 2015;25(3):203‐12. [DOI: 10.1089/cap.2014.0104; PMC4403224; PUBMED: 25885010] - DOI - PMC - PubMed
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Blader 2009 {published data only}
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ISRCTN95609637 {published data only}
    1. ISRCTN95609637. Relapse prevention in children and adolescents with aggressive behaviour problems treated with risperidone [Relapse prevention in children and adolescents with Siagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM‐IV) Conduct Disorder treated with risperidone: a randomized double blind, placebo‐controlled, discontinuation Study]. www.isrctn.com/ISRCTN95609637 (first received 27 January 2012). [DOI: 10.1186/ISRCTN95609637] - DOI
Kuperman 2010 {published data only}
    1. Kuperman S, Calarge C, Kolar A, Holman T, Barnett M, Perry P. An open‐label trial of aripiprazole in the treatment of aggression in male adolescents diagnosed with conduct disorder. Annals of Clinical Psychiatry 2011;23(4):270‐6. [22073384] - PubMed
Masi 2006 {published data only}
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NCT00279409 {published data only}
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NCT00550147 {published data only}
    1. NCT00550147. Quetiapine and concerta in the treatment for ADHD and aggressive behavior [An open‐label study of quetiapine added to oros methylphenidate in the treatment of ADHD and aggressive behavior]. clinicaltrials.gov/ct2/show/NCT00550147 (first received 25 October 2007). [www.druglib.com/trial/47/NCT00550147.html]
Reyes 2006b {published data only}
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Safavi 2016 {published data only}
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Teixeira 2013a {published data only}
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Turgay 2002 {published data only}
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References to studies awaiting assessment

IRCT201211051743N10 {published data only}
    1. Holsboer‐Trachsler E, Jahangard L, Akbarian S, Haghighi M, Ahmadpanah M, Keshavarzi A, et al. Children with ADHD and symptoms of opposite defiant disorder improved in behavior when treated with methylphenidate and adjuvant risperidone, though weight gain was also observed. Neuropsychopharmacology 2016;41:S134. [DOI: 10.1038/npp.2016.240; IRCT201211051743N10] - DOI - PubMed
    1. IRCT201211051743N10. A double‐blind, placebo‐controlled study on the efficacy of risperidone adjunctive to methylphenidate in patients with ADHD. www.irct.ir/searchresult.php?id=1743&number=10 (first received 26 January 2013).
NCT02063945 {published data only}
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References to ongoing studies

NCT00794625 {published data only}
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