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Meta-Analysis
. 2006 Apr 19;2006(2):CD004578.
doi: 10.1002/14651858.CD004578.pub3.

Aripiprazole for schizophrenia

H G El-Sayeh  1 , C Morganti
Affiliations
Meta-Analysis

Aripiprazole for schizophrenia

H G El-Sayeh et al. Cochrane Database Syst Rev. .

Abstract

Background: Treatment of people with schizophrenia using older typical antipsychotic drugs such as haloperidol can be problematic. Many fail to respond to these older antipsychotics and more people experience disabling adverse effects. Aripiprazole is said to be one of a new generation of atypical antipsychotics with good antipsychotic properties and minimal adverse effects.

Objectives: To evaluate the effects of aripiprazole for people with schizophrenia and schizophrenia-like psychoses.

Search strategy: We searched the Cochrane Schizophrenia Group's Register (September 2005) which is based on regular searches of BIOSIS, CENTRAL, CINAHL, EMBASE, MEDLINE and PsycINFO. We inspected references of all identified studies for further trials. We contacted relevant pharmaceutical companies, the FDA and authors of trials for additional information.

Selection criteria: All clinical randomised trials comparing aripiprazole with placebo, typical or atypical antipsychotic drugs for schizophrenia and schizophrenia-like psychoses.

Data collection and analysis: We extracted data independently. For homogenous dichotomous data we calculated random effects, relative risk (RR), 95% confidence intervals (CI) and, where appropriate, numbers needed to treat (NNT) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD).

Main results: Despite the fact that 7110 people participated in fifteen randomised aripiprazole studies, we were unable to extract any usable data on death, service outcomes, general functioning, behaviour, engagement with services, satisfaction with treatment; economic outcomes or cognitive functioning. Study attrition was very large and data reporting poor. Compared with placebo, aripiprazole significantly decreased relapse in both the short and medium term (n=300, 1 RCT, RR 0.66 CI 0.5 to 0.8, NNT 5 CI 4 to 8). It also produced better compliance with study protocol (n=2271, 8 RCTs, RR 0.72 CI 0.5 to 0.97, NNT 26 CI 16 to 239). Aripiprazole may decrease prolactin levels below that expected from placebo (n=305, 1 RCT, RR 0.32 CI 0.1 to 0.8, NNT 14 CI 11 to 50). Compared with typical antipsychotics there were no significant benefits for aripiprazole with regards to global state, mental state, quality of life or leaving the study early. Both groups reported similar rates of adverse effects, with the exception of akathisia (n= 955 RR 0.31 CI 0.2 to 0.6, NNT 20 CI 17 to 32) and the need for antiparkinson medication (n=1854, 4 RCTs, RR 0.45 CI 0.3 to 0.6, NNT 4 CI 3 to 5) which were lower in those receiving aripiprazole. When compared with olanzapine and risperidone, aripiprazole was no better or worse on outcomes of global state and leaving the study early. The rates of adverse effects were also similar, with the exception of less elevation of prolactin (n=301, 1 RCT, RR 0.04 CI 0.02 to 0.1, NNT 2 CI 1 to 2.5) and less prolongation of the average QTc (30 mg/day) (n=200, 1 RCT, WMD -10.0, CI -16.99 to -3.0) compared with risperidone. When compared with standard care (mixed group receiving typical and atypical antipsychotics) one aripiprazole study did have significantly less people not responding to treatment (n=1599, RR 0.70 CI 0.7 to 0.8, NNT 5 CI 4 to 6 ), not satisfied with care (n=1599, RR 0.62 CI 0.6 to 0.7, NNT 4 CI 4 to 5) and less people leaving the study early (n=1599, 1 RCT, RR 0.81 CI 0.7 to 0.9, NNT 13 CI 8 to 39). Results from the five new papers identified from the updated review search, did not significantly alter the main results or conclusions of the original review.

Authors' conclusions: Aripiprazole may be effective for the treatment of schizophrenia, but it does not differ greatly from typical and atypical antipsychotics with respect to treatment response, efficacy or tolerability. In comparison with typical antipsychotics, aripiprazole may have a lower risk of akathisia, and in comparison to atypical antipsychotics, less risk of raised prolactin and prolongation of the QTc interval. Clearly reported pragmatic short, medium and long term randomised controlled trials should be undertaken to determine its position in everyday clinical practice.

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Conflict of interest statement

Hany George El‐Sayeh ‐ none known.

Carla Morganti ‐ none known.

Figures

1.1
1.1. Analysis
Comparison 1 ARIPIPRAZOLE versus PLACEBO, Outcome 1 Global state: 1. Relapse.
1.2
1.2. Analysis
Comparison 1 ARIPIPRAZOLE versus PLACEBO, Outcome 2 Global state: 2. Poor compliance with study protocol due to lack of efficacy, deterioration or psychosis.
1.3
1.3. Analysis
Comparison 1 ARIPIPRAZOLE versus PLACEBO, Outcome 3 Global state: 3. Needing additional antipsychotic medication.
1.4
1.4. Analysis
Comparison 1 ARIPIPRAZOLE versus PLACEBO, Outcome 4 Global state: 4. Needing additional benzodiazepines.
1.5
1.5. Analysis
Comparison 1 ARIPIPRAZOLE versus PLACEBO, Outcome 5 Adverse effects: 1. Clinically important specific adverse effects.
1.6
1.6. Analysis
Comparison 1 ARIPIPRAZOLE versus PLACEBO, Outcome 6 Adverse effects: 2. Average change in QTc interval (ms) from baseline.
1.7
1.7. Analysis
Comparison 1 ARIPIPRAZOLE versus PLACEBO, Outcome 7 Adverse effects: 3. Physiological (serum) measures.
1.8
1.8. Analysis
Comparison 1 ARIPIPRAZOLE versus PLACEBO, Outcome 8 Leaving the study early.
2.1
2.1. Analysis
Comparison 2 ARIPIPRAZOLE versus TYPICAL ANTIPSYCHOTICS, Outcome 1 Global state: 1. Poor compliance with study protocol due to lack of efficacy, deterioration or psychosis.
2.2
2.2. Analysis
Comparison 2 ARIPIPRAZOLE versus TYPICAL ANTIPSYCHOTICS, Outcome 2 Global state: 2. Needing additional antipsychotic medication.
2.3
2.3. Analysis
Comparison 2 ARIPIPRAZOLE versus TYPICAL ANTIPSYCHOTICS, Outcome 3 Global state: 3. Needing additional benzodiazepines.
2.4
2.4. Analysis
Comparison 2 ARIPIPRAZOLE versus TYPICAL ANTIPSYCHOTICS, Outcome 4 Mental state: Treatment response (defined by CGI or PANSS).
2.5
2.5. Analysis
Comparison 2 ARIPIPRAZOLE versus TYPICAL ANTIPSYCHOTICS, Outcome 5 Adverse effects: Clinically important specific adverse effects.
2.6
2.6. Analysis
Comparison 2 ARIPIPRAZOLE versus TYPICAL ANTIPSYCHOTICS, Outcome 6 Quality of life: No clinically important improvement in quality of life (defined by QLS score).
2.7
2.7. Analysis
Comparison 2 ARIPIPRAZOLE versus TYPICAL ANTIPSYCHOTICS, Outcome 7 Leaving the study early.
3.1
3.1. Analysis
Comparison 3 ARIPIPRAZOLE versus ATYPICAL ANTIPSYCHOTICS, Outcome 1 Global state: Poor compliance with study protocol due to lack of efficacy, deterioration or psychosis.
3.2
3.2. Analysis
Comparison 3 ARIPIPRAZOLE versus ATYPICAL ANTIPSYCHOTICS, Outcome 2 Adverse effects: 1. Clinically important specific adverse effects.
3.3
3.3. Analysis
Comparison 3 ARIPIPRAZOLE versus ATYPICAL ANTIPSYCHOTICS, Outcome 3 Adverse effects: 2. Average change in QTc interval (ms) from baseline.
3.4
3.4. Analysis
Comparison 3 ARIPIPRAZOLE versus ATYPICAL ANTIPSYCHOTICS, Outcome 4 Adverse effects: 3. Physiological (serum) measures.
3.5
3.5. Analysis
Comparison 3 ARIPIPRAZOLE versus ATYPICAL ANTIPSYCHOTICS, Outcome 5 Leaving the study early.
4.1
4.1. Analysis
Comparison 4 ARIPIPRAZOLE versus STANDARD CARE, Outcome 1 Global state: Not responded.
4.2
4.2. Analysis
Comparison 4 ARIPIPRAZOLE versus STANDARD CARE, Outcome 2 Satisfaction with treatment: Not satisfied with care.
4.3
4.3. Analysis
Comparison 4 ARIPIPRAZOLE versus STANDARD CARE, Outcome 3 Leaving the study early.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Adson 2003 {unpublished data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 4. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:176‐232.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets; medical review part 1. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:1‐50.
Carson 2000 a {published data only}
    1. Anutosh S, Ali MW, Ingenito G, Carson WH. Controlled study of aripiprazole and haloperidol in schizophrenia. European Psychiatry 2002;Suppl 1:103s.
    1. Carson WH, Ali M, Dunbar G, Ingenito G, Saha AR. A double‐blind, placebo‐controlled trial of aripiprazole and haloperidol. Schizophrenia Research 2001;1‐2:221‐2. [MEDLINE: ]
    1. Carson WH, Ali M, Saha AR, Dunbar GC, Ingenito G. A double‐blind, placebo‐controlled trial of aripiprazole and haloperidol in patients with schizophrenia or schizoaffective disorder. 39th Annual Meeting of the American College of Neuropsychopharmacology; 2000; Dec 10‐14; San Juan; Puerto Rico. 2000. [MEDLINE: ]
    1. Carson WH, Kane JM, Ali M, Dunbar GC, Ingenito G. Efficacy of aripiprazole in psychotic disorders: comparison with haloperidol and placebo. Journal of the European College of Neuropsychopharmacology 2000;10(Suppl 3):S309.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 1. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:1‐50.
Carson 2002 b {published data only}
    1. Carson W, McQuade R, Saha A, Torbeyns A, Stock E. Aripiprazole versus placebo for relapse prevention in patients with chronic schizophrenia. Journal of the European College of Neuropsychopharmacology. 2002; Vol. 12, issue Supplement 3:s288.
    1. Carson W, Pigott T, Saha A, Ali M, McQuade RD, Torbeyns AF, et al. Aripiprazole versus placebo in the treatment of stable, chronic schizophrenia. 156th Annual Meeting of the American Psychiatric Association; 2003 May 17‐22; San Francisco, USA. 2003.
    1. Carson WH, Pigott TA, Saha AR, Ali MW, McQuade RD, Torbeyns AF, Stock EG. Aripiprazole vs. placebo in the treatment of chronic schizophrenia. International Journal of Neuropsychopharmacology 2002;Suppl 1:S187.
    1. Casey D, Saha A, Marcus R, Carson WH, McQuade RD, Torbeyns AF, Stock E. Aripiprazole versus placebo for relapse prevention in patients with chronic schizophrenia. Schizophrenia Research 2003;60:276. [MEDLINE: ; PMID 12701664]
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm 2002:111‐75.
Csernansky 2003 {unpublished data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 1. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:1‐50.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 2. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:51‐110.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Daniel 2000 {published data only}
    1. Daniel DG, Saha AR, Ingenito G, Carson WH, Dunbar G. Aripiprazole, a novel antipsychotic: overview of a phase II study result. International Journal of Neuropsychopharmacology 2000;Suppl 1:S157.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 1. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:1‐50.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
    1. Saha AR, Petrie JL, Ali MW. Safety and efficacy profile of aripiprazole, a novel antipsychotic. Schizophrenia Research 1999;1‐3:295. [MEDLINE: ]
Daniel 2004 {published data only}
    1. Daniel DG, Stock EG, Wilber CH, Marcus RN, Carson Jr WH, Manos G, Iwamoto T. Intramuscular aripiprazole in acutely agitated psychotic patients. 157th Annual Meeting of the American Psychiatric Association; 2004 May 1‐6; New York, Usa. 2004. [APA Conference Abstracts NR612]
    1. Kungel M, Daniel D, Stock E, Wilber R, Marcus R, Carson W, Manos G, Iwamoto T. Efficacy and safety of intramuscular aripiprazole in acutely agitated patients with psychosis. Thematic Conference of the World Psychiatric Association on "Treatments in Psychiatry: An Update"; 2004 Nov 10‐13; Florence, Italy. 2004. [PO1.81.]
Kane 2003 {unpublished data only}
    1. Kane J, Carson W, Kujawa M, Stringfellow J, Marcus R, Sanchez R, et al. Aripiprazole vs. perphenazine in treatment‐resistant schizophrenia. 156th Annual Meeting of the American Psychiatric Association; 2003 May 17‐22; San Francisco, USA. 2003.
    1. Kane J, Carson Wh, Kujawa M, Stringfellow J, Marcus R, Sanchez R, Iwamoto T, Meltzer H. Aripiprazole in Treatment‐Resistant Schizophrenia: a 6‐Week Double‐ Blind Comparison Study Versus Perphenazine. Schizophrenia Research 2004;67(1):155‐6. [ISI 000188788100371]
    1. McQuade R, Jody D, Kane J, Carson W, Kujawa M, Stringfellow J, Marcus R, Sanchez R, Meltzer HY. Efficacy and safety of aripiprazole versus perphenazine in treatment‐resistant schizophrenia. Journal of the European College of Neuropsychopharmacology 2003;13(4):S326. [P.2.105]
    1. McQuade R, Jody D, Kane J, Carson W, Kujawa M, Stringfellow J, Marcus R, Sanchez R, Meltzer HY. Efficacy and safety of aripiprazole versus perphenazine in treatment‐resistant schizophrenia. Journal of the European College of Neuropsychopharmacology 2003;13(4):S326. [P.2.105]
    1. Meltzer HY, Kujawa MJ, Carson Jr WH, Stringfellow J, Iwamoto T, Marcus RN, Stock EG. Aripiprazole and perphenazine in severe treatment‐resistant schizophrenia. 157th Annual Meeting of the American Psychiatric Association; 2004 May 1‐6; New York, Usa. 2004. [APA Conference Abstracts NR622]
Kern 2001 {published data only}
    1. Carson W, Cornblatt B, Saha A, Ali M, Kern R, Green M. Neurocognitive benefits of aripiprazole versus olanzapine in stable psychosis. Journal of the European College of Neuropsychopharmacology 2002;Supplement 3:S291.
    1. Cornblatt B, Kern RS, Carson WH, Ali MW, Luo X, Green M. Neurocognitive effects of aripiprazole versus olanzapine in stable psychosis. International Journal of Neuropsychopharmacology 2002;Suppl. 1:s185.
    1. Cornblatt B, Kern RS, Carson WH, Stock E, Ali M, Ingenito G, Green MF. Neurocognitive effects of aripiprazole versus olanzapine in patients with stable psychosis. Journal of Psychopharmacology 2002;16(3):A15.
    1. Cornblatt B, Kern RS, Carson WH, Stock E, Ali M, Ingenito G, Green MF. Neurocognitive effects of aripiprazole versus olanzapine in patients with stable psychosis. Schizophrenia Research 2002;3(Suppl. 1):27. [MEDLINE: ]
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Kujawa 2002 {published data only}
    1. Archibald DG, Manos G, Tourkodimitris S, Iwamoto T, Carson WH, Stock E, Marcus R. Reduction in negative symptoms of schizophrenia during long‐term therapy with aripiprazole. Schizophrenia Research 2003;60:271. [MEDLINE: ; PMID 12701664]
    1. Archibald Dg, Manos G, Stock E, Jody D, Tourkodimitris S, Marcus R, Iwamoto T, Yamamoto Y. Effects of Long‐Term Aripiprazole Therapy on the Negative Symptoms of Schizophrenia. Schizophrenia Research 2004;67(1):155. [ISI 000188788100369]
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 1. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:1‐50.
    1. Kasper S, Lerman MN, McQuade RD, Saha A, Carson WH, Ali M, Archibald D, Ingenito G, Marcus R, Pigott T. Efficacy and safety of aripiprazole vs. haloperidol for long‐term maintenance treatment following acute relapse of schizophrenia. International Journal of Neuropsychopharmacology 2003;6(4):325‐37. [PMID 14609439; EMBASE: 2004054004] - PubMed
    1. Kostic D, Manos G, Stock E, Jody D, Archibald D, Tourkodimitris S, Marcus R. Long‐term effects of aripirazole on the negative symptoms of schizophrenia. Journal of the European College of Neuropsychopharmacology 2003;13(4):S328. [P.2.111]
Marcus 2005 {published data only}
    1. Marcus RN. Efficacy and safety of lower doses of aripiprazole. 158th Annual Meeting of the American Psychiatric Association; 2005 May 21‐26; Atlanta, USA. 2005. [MEDLINE: ]
McQuade 2003 {unpublished data only}
    1. Abou Gharbia N, McQuade R, Jody D, Kujawa M, Carson W, Iwamoto T, Archibald D, Stock E. Comparative Study of the long‐term effects of aripiprazole and olanzapine treatment on body weight. Thematic Conference of the World Psychiatric Association on "Treatments in Psychiatry: An Update"; 2004 Nov 10‐13; Florence, Italy. 2004. [COMPARATIVE STUDY OF THE LONG‐TERM]
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐175.
    1. Jody D, Mcquade Rd, Kujawa M, Carson W, Iwamoto T, Archibald D, Stock E. Long‐Term Weight Effects of Aripiprazole Versus Olanzapine. Schizophrenia Research 2004;67(1):187. [ISI 000188788100447]
    1. McQuade RD, Jody DN, Kujawa MJ, Carson WH, Iwamoto T, Archibald DG, et al. Long‐term weight effects of aripiprazole vs. olanzapine.. 156th Annual Meeting of the American Psychiatric Association; 2003 May 17‐22; San Francisco, USA. 2003.
    1. McQuade RD, Stock E, Marcus R, Jody D, Gharbia NA, Vanveggel SAD, Carson WH. A comparison of weight change during treatment with olanzapine or aripiprazole: results from a randomized, double‐blind study. Journal of Clinical Psychiatry 2004;65(Suppl 18):47‐56. [MEDLINE: ] - PubMed
Oren 2005 {published data only}
    1. Oren D, Marcus R, Kostic D, McQuade R, Iwamoto T, Archibald D. Efficacy and Safety of Intramuscular Aripiprazole, Haloperidol or Placebo in Acutely Agitated Patients with Schizophrenia or Schizoaffective Disorder. Schizophrenia Bulletin 2005;31:499. [116266]
    1. Yocca F. Intramuscular aripiprazole in acute schizophrenia: A pivotal phase‐three study. 158th Annual Meeting of the American Psychiatric Association; 2005 May 21‐26; Atlanta, USA. 2005. [Conference Abstract NR274]
Potkin 2003 {published data only}
    1. Carson WH, Saha AR, Ali M, Dunbar GC, Ingenito G. Aripiprazole and risperidone versus placebo in schizophrenia and schizoaffective disorder. Annual Meeting of the American Psychiatric Association; 2001 May 5‐10; LA, USA. Marathon Multimedia, 2001. [MEDLINE: ]
    1. Carson WH, Saha AR, Mirza A, Dunbar GC, Ingenito G. Aripiprazole and risperidone versus plaebo in schizophrenia and schizoaffective disorder. 155th Annual Meeting of the American Psychiatric Association; May 18‐23; Philadelphia, USA. 2002.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 1. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:1‐50.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 4. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:176‐232.
Riera 2004 {published data only}
    1. L'Italien GJ, Tandon R, Han J, Li H, Ray S, Carson W. Schizophrenic patients treated with aripiprazole exhibit improved overall effectiveness compared to patients treated with atypical antipsychotics. Thematic Conference of the World Psychiatric Association on "Treatments in Psychiatry: An Update"; 2004 Nov 10‐13; Florence, Italy. 2004. [PO1.76.]
    1. McQuade RD. Investigator assessment of clinical parameters after initiating aripiprazole therapy. 158th Anual Meeting of the American Psychiatric Association; 2005 May 21‐26; Atlanta, USA. 2005. [APA conference abstracts NR222]
    1. Octavio I, Tandon R, Stock E, Riera L, Kujawa M, Lam S, Pans M, Iwamoto T, Carson W. A naturalistic study of aripiprazole treatment in a general psychiatric setting. Thematic Conference of the World Psychiatric Association on "Treatments in Psychiatry: An Update"; 2004 Nov 10‐13; Florence, Italy. 2004. [PO1.83.]
    1. Riera L, Hu R, Stock E, Nyilas M, Torbeyns A, Borian F, Gentile K, Carson W, Iwamoto T. Broad effectivness trial with aripiprazole. 157th Annual Meeting of the American Psychiatric Association; 2004 May 1‐6; New York, USA. 2004. [Conference Abstract NR309]
    1. Tandon R, Han J, Litalien G, Ray S, Carson Jr WH. Investigator's assessment questionnaire of antipsychotics' effectiveness. 157th Annual Meeting of the American Psychiatric Association; 2004 May 1‐6; New York, USA. 2004. [APA Conference Abstracts NR609]
Stock 2005 {published data only}
    1. McQuade R, Kostic D, Marcus R, Carson W, Torbeyns A, Kerselaers W, Yocca F. Aripiprazole versus olanzapine in a 52‐week open label extension study. Schizophrenia Bulletin 2005;31:496‐7. [116194]
    1. Stock EG. Aripiprazole versus olanzapine in schizophrenia: A 52 week, open‐label study. 158th Annual Meeting of the American Psychiatric Association; 2005 May 21‐26; Atlanta, USA. 2005. [Conference Abstract NR 267]

References to studies excluded from this review

Auby 2002 {published data only}
    1. Auby P, Saha A, Ali M, Ingenito G, Wilber R, Bramer S. Safety and tolerability of aripiprazole at doses higher than 30 mg. Journal of the European College of Neuropsychopharmacology 2002;suppl 3:S288.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 111‐75.
    1. Saha A, Ali MW, Ingenito GG, Wilber R, Luo X, Bramer S. Safety and tolerability of aripiprazole at doses higher than 30 mg. International Journal of Neuropsychopharmacology 2002;suppl 1:S185.
    1. Saha AR, Ali MW, Ingenito GG, Wilber R, Luo X, Bramer S. Safety and tolerability of aripiprazole at doses higher than 30mg. 155th Annual Meeting of the American Psychiatric Association; 2002 May 18‐23; Philadelphia, PA, USA. 2002.
Carson 2002 a {published data only}
    1. Carson WH, Ingenito GG, McQuade RD, Stock EG, Iwamoto T. [Schizophrenia; safety/tolerability of aripiprazole]. XIIth World Congress of Psychiatry; Aug 24‐29; Yokohama, Japan. 2002.
Casey 2003 {published data only}
    1. Casey D, Saha AR, Ali MW, Jody DN, Kujawa MJ, Stock EG, Ingenito GG. Switching to aripiprazole monotherapy. International Journal of Neuropsychopharmacology 2002;Suppl 1:S187.
    1. Casey DE, Carson WH, Saha AR, Liebeskind A, Ali MW, Jody D, et al. Switching patients to aripprazole from other antipsychotic agents: a multicenter randomised study. Psychopharmacology 2003;166:391‐99. - PubMed
    1. Casey DE, Saha AR, Ali MW, Jody D, Kujawa MJ, Stock EG, Ingenito GG. Switching to aripiprazole monotherapy. 155th Annual Meeting of the American Psychiatric Association; 2002 May 18‐23; Philadelphia, PA, USA. 2002.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
    1. Kujawa M, Saha AR, Ali MW, Jody DN, McQuade RD, Ingenito GG. Switching to aripiprazole monotherapy. Schizophrenia Research 2003;60:290. [MEDLINE: ; PMID 12701664]
Kujawa 2003 {published data only}
    1. Kujawa M, Stringfellow J, Hardy S, Ali M, Iwamoto T, Lam S, Marcus R, Stock E. Efficacy, Safety, and Tolerability of Aripiprazole in Patients With Schizoaffective Disorder. Schizophrenia Research 2004;67(1):156. [ISI 000188788100372]
    1. Kujawa MJ, Stringfellow J, Hardy S, Ali M, Marcus RN, Stock EG. The efficacy of aripiprazole in patients with schizoaffective disorder. 156th Annual Meeting of the American Psychiatric Association; 2003 May 17‐22; San Francisco, USA. 2003. [[NR536]]
Mallikaarjun 2000 {published data only}
    1. Mallikaarjun S, Salazar DE, Bramer SL. Pharmacokinetics, tolerability, and safety of aripiprazole following single and multiple oral dose administration. Journal of the European College of Neuropsychopharmacology 2000;Suppl 3:S306.
    1. Mallikaarjun S, Salazar DE, Bramer SL. The pharmacokinetics, tolerability, and safety of aripiprazole following single and multiple oral dose administration. International Journal of Neuropsychopharmacology 2000;Suppl 1:S123.
Marcus 2003 {published data only (unpublished sought but not used)}
    1. Marcus RN, Kostic D, Stringfellow J, Hardy S, Carson WH, Stock EG. Efects of aripiprazole on Excitement and Hostility: Symptoms of schizophrenia. American Psychiatric Association 156th Annual Meeting, 17‐22 May, San Francisco, USA. 2003.
Petrie 1997 {published and unpublished data}
    1. Petrie JL, Saha JR, McEvoy JP. Aripiprazole, a new typical antipsychotic: phase 2 clinical trial result. 10th European College of Neuropsychopharmacology Congres; Sep 13‐17; Vienna, Austria. 1997.
Saha 2004 {published data only}
    1. Saha AR, Brown D, McEvoy J, Ali M, Abou‐Gharbia N, Stock S, Iwamoto T. Tolerability and efficacy of aripiprazole in patients with first episode schizophrenia: An open label pilot study. Twelft Biennial Winetr Workshop on Schizophrenia, Davos, Switzwerland, 7th‐13th February. 2004.
Stroup 2003 {published data only}
    1. Stroup TS, McEvoy JP, Swartz MS, Byerly MJ, Glick ID, Canive JM, McGee MF, Simpson GM, Stevens MC, Lieberman JA. The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project: Schizophrenia trial design and protocol development. Schizophrenia Bulletin 2003;29(1):15‐31. [EMBASE 2003292851] - PubMed

References to studies awaiting assessment

Anonymous 2002 {published data only}
    1. Anonymous. New Antipsychotic, new benefits?. Current Drug Discovery 2002;Oct:11.
Anonymous 2003 {published data only}
    1. Anonymous. Aripiprazole (Abilify) for schizophrenia. Medical Letter on Drugs and Therapeutics 2003;45:15‐16. - PubMed
Kujawa 2004 {published data only}
    1. Kujawa M, Stringfellow J, Hardy S, Ali M, Iwamoto T, Lam S, Marcus R, Stock E. Efficacy, Safety, and Tolerability of Aripiprazole in Patients With Schizoaffective Disorder. Schizophrenia Research 2004;67(1):156. [ISI 000188788100372]
Ramamurthy 2000 {published data only}
    1. Palazidou E. A multicentre, double‐blind, randomised comparative study of aripiprazole and olanzapine in the treatment of patients with acute schizophrenia. National Research Register 2002; Vol. 1.
    1. Ramamurthy V. A multi‐centre, d‐b, randomised comparative study of aripiprazole and olanzapine in the treatment of patients with acute schizophrenia. National Research Register 2000.
Study 95002 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 95003 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 95201 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 97203 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 97301 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 97303 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 98202 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 98204 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 98218 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 98220 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 98222 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.

References to ongoing studies

Study 138001a {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 138002a {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 138003 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 138032 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.
Study 138047a {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets, medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002:111‐75.

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References to other published versions of this review

El‐Sayeh 2006
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