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Meta-Analysis
. 2011 Aug 10;2011(8):CD006622.
doi: 10.1002/14651858.CD006622.pub2.

Aripiprazole versus placebo for schizophrenia

Ravindra B Belgamwar  1 , Hany George G El-Sayeh
Affiliations
Meta-Analysis

Aripiprazole versus placebo for schizophrenia

Ravindra B Belgamwar et al. Cochrane Database Syst Rev. .

Abstract

Background: First generation 'typical' antipsychotics such as chlorpromazine and haloperidol have been the mainstay of treatment up until the introduction of the second generation 'atypical' antipsychotics such as risperidone and olanzapine. Typical and atypical antipsychotics do provide a treatment response for most people with schizophrenia, whether a reduction in psychotic episodes or a lessening in the severity of their illness. However, a proportion of people still do not respond adequately to antipsychotic medication. Additionally, atypical and especially typical antipsychotics are associated with serious adverse effects, which can often compromise compliance with medication and therefore increase the incidences of relapse. In this review we examine the effects of aripiprazole compared with placebo.

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

Search strategy: We searched the Cochrane Schizophrenia Group Trials Register (January 2008) which is based on regular searches of BIOSIS, CENTRAL, CINAHL, EMBASE, MEDLINE and PsycINFO. For this update, we carried out an initial search in May 2007 and a second search in August 2008.

Selection criteria: We included all randomised trials comparing aripiprazole with placebo in people with schizophrenia or schizophrenia-like psychosis.

Data collection and analysis: We extracted data independently. For dichotomous data we calculated risk ratios (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis based on a fixed-effect model. We calculated numbers needed to treat/harm (NNT/NNH) where appropriate. For continuous data, we calculated mean differences (MD) again based on a fixed-effect model.

Main results: Despite the fact that 2585 people participated in nine 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. In general, study attrition was very large for all studies over four weeks' duration. There was high attrition in most of the included studies. Fewer people left the aripiprazole group compared with those in the placebo group (n = 2585, 9 RCTs, RR 0.73 CI 0.60 to 0.87). Compared with placebo, aripiprazole significantly decreased relapse in both the short (n = 310, 1 RCT, RR 0.59 CI 0.45 to 0.77) and medium term (n = 310, 1 RCT, RR 0.66 CI 0.53 to 0.81). It also produced better compliance with study protocol (n = 2275, 8 RCTs, RR 0.74 CI 0.59 to 0.93). Aripiprazole may decrease prolactin levels below those expected from placebo (n = 305, 2 RCT, RR 0.21 CI 0.11 to 0.37). Insomnia (˜23%) and headaches (˜15%) were commonly reported in both groups, with no significant difference.

Authors' conclusions: Aripiprazole may be effective for the treatment of schizophrenia. Aripiprazole has a lower 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.

PubMed Disclaimer

Conflict of interest statement

Dr Ravindra Belgamwar ‐ none. Dr Hany George El‐Sayeh ‐ none.

Figures

1
1
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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.
1.9
1.9. Analysis
Comparison 1 ARIPIPRAZOLE versus PLACEBO, Outcome 9 concomitant medication ‐ anxiolytics.
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD006622

References

References to studies included in this review

Adson 2003 {unpublished data only}
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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.
    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. Proceedings of the 39th Annual Meeting of the American College of Neuropsychopharmacology; 2000 Dec 10‐14; San Juan; Puerto Rico. 2000.
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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;12(Suppl 3):S288.
    1. Carson W, Pigott T, Saha A, Ali M, McQuade RD, Torbeyns AF, Stock E. Aripiprazole versus placebo in the treatment of stable, chronic schizophrenia. Proceedings of the156th 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.
    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.
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Daniel 2000 {published data only}
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    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.
Daniel 2004 {published data only}
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    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.
Marcus 2005 {published data only}
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    1. Marcus RN. Efficacy and safety of lower doses of aripiprazole. Proceedings of the 158th Annual Meeting of the American Psychiatric Association; 2005 May 21‐26; Atlanta, USA. 2005.
Oren 2005 {published data only}
    1. Andrezina R, Josiassen R, Marcus R, Oren D, Manos G, Stcok E, Carson W, Iwamoto T. Intramuscular aripripazole for the treatment of acute agitation in patients with schizophrenia or schizoaffective disorder: a double blind, placebo controlled comparison with intramuscular haloperidol. Psychopharmacology 2006;188:281‐92. - PubMed
    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.
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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. Proceedings of the Annual Meeting of the American Psychiatric Association; 2001 May 5‐10; LA, USA. Marathon Multimedia, 2001.
    1. Carson WH, Saha AR, Mirza A, Dunbar GC, Ingenito G. Aripiprazole and risperidone versus placebo in schizophrenia and schizoaffective disorder. Proceedings of the 155th Annual Meeting of the American Psychiatric Association; 2002 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.
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References to studies excluded from this review

Allain 2005 {published and unpublished data}
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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 AR, 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.
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Beuzen 2005 {published data only}
    1. Beuzen J‐N, Pans M, Modell S, Hagens P, McQuade R, Iwamoto T, Carson W. Naturalistic study of aripiprazole treatment. Proceedings of the XIII World Congress of Psychiatry; 2005 10‐15th Sept; Cairo, Egypt. 2005.
Blonde 2004 {published data only}
    1. Blonde L, Ray S, Corey‐Lisle PK, Cislo PR, L'Italien G. The risk of new‐onset type 2 diabetes and coronary heart disease in chronic schizophrenic patients treated with aripiprazole and olanzapine. Journal of the European College of Neuropsychopharmacology 2004;14(Suppl 3):S275.
Carson 2002 a {published data only}
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Carson W, McQuade 2003 {published data only}
    1. Carson W, McQuade R, Abou‐Gharbia N, Iwamoto T, Archibald D, Stock E. Long‐term weight effects of aripiprazole and olanzapine: results from a 26‐week double‐blind comparison study. Journal of the European College of Neuropsychopharmacology 2004;14(Suppl 3):S259.
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.
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    1. Kujawa M, Saha AR, Ali MW, Jody DN, McQuade RD, Ingenito GG. Switching to aripiprazole monotherapy. Schizophrenia Research 2003;60:290.
Chan 2007 {published data only}
    1. Chan H‐Y, Lin W‐W, Lin S‐K, Hwang T‐J, Su T‐P, Chiang S‐C, Hwu H‐G. Efficacy and safety of aripiprazole in the acute treatment of schizophrenia in Chinese patients with risperidone as an active control: a randomized trial. Journal of Clinical Psychiatry 2007;68(1):29‐36. - PubMed
Chen 2005 b {published data only}
    1. Chen J‐D, Zhao J‐P, Li L‐H, Guo X‐F, Zhai J‐G, Wang C‐Y, Xie S‐P, Gao C‐G, Ding Y, Chen Y‐G. A multicenter, randomized and double‐blind controlled clinical trial of aripiprazole in treatment of schizophrenia. Chinese Journal of New Drugs and Clinical Remedies 2005;24(11):845‐8.
Chrzanowski 2006 {published data only}
    1. Chrzanowski WK, Marcus RN, Torbeyns A, Nyilas M, McQuade RD. Effectiveness of long‐term aripiprazole therapy in patients with acutely relapsing or chronic, stable schizophrenia: a 52‐week, open‐label comparison with olanzapine. Psychopharmacology 2006;189(2):259‐66. - PubMed
Corey‐Lisle 2006 {unpublished data only}
    1. Corey‐Lisle PK, Kolotkin RL, Crosby RD, L'Italien GJ. Changes in weight and weight‐related quality of life in aripiprazole versus standard‐of‐care treatment. Proceedings of the 159th Annual Meeting of the American Psychiatric Association; 2006 May 20‐25, Toronto, Canada. 2006.
Daniel 2006 {unpublished data only}
    1. Daniel DG, Crandall D, Manos G, McQuade RD, Gutierrez‐Esteinou R, Pikalov AA, Oren D. Transitioning from intramuscular (IM) to oral aripiprazole in patients with schizophrenia. Proceedings of the 159th Annual Meeting of the American Psychiatric Association; 2006 May 20‐25, Toronto, Canada. 2006.
Fan 2005 a {published data only}
    1. Fan W‐L, Yu C‐M, Wen J‐S. Efficacy analysis of aripiprazole and clozapine in the treatment of schizophrenia. Journal of North Sichuan Medical College 2005;20(4):377‐9.
Gismondi R, Mel2 {published data only}
    1. Gismondi R, Meltzer H, Kujawa M, Carson W, Stringfellow J, Iwamoto T, Marcus R, Stock E. Aripiprazole versus perphenazine in treatment‐resistant schizophrenia. Proceedings of the XXIVth Collegium Internationale Neuro‐Psychopharmacologicum Congress; 2004 June 20–24, Paris, France 2004.
Han 2005 a {published data only}
    1. Han P, Zhang Y‐H, Zhang Y‐Q. A controlled study of schizophrenia treated with aripiprazole and clozapine. Chinese Journal of Rehabilitation Theory and Practice 2005;11(10):853‐4.
Hwang 2005 {published data only}
    1. Hwang TJ, Chan HY, Lin WW, Lin SK, Hwu HG, Cheng MY, Forbes R. Aripiprazole versus risperidone in the treatment of acutely relapsed patients with schizophrenia in Taiwan: a randomized controlled trial. Journal of the European College of Neuropsychopharmacology 2005;15(Suppl 3):S497.
Jody 2004 {published data only}
    1. Jody D, 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. Proceedings of the XXIVth Collegium Internationale Neuro‐Psychopharmacologicum Congress; 2004 June 20–24, Paris, France 2004.
Kane 2003 {unpublished data only}
    1. Kane J, Carson W, Kujawa M, Stringfellow J, Marcus R, Sanchez R, Meltzer HY. Aripiprazole vs. perphenazine in treatment‐resistant schizophrenia. Proceedings of the 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.
    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.
    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.
    1. Meltzer HY, Kujawa MJ, Carson Jr WH, Stringfellow J, Iwamoto T, Marcus RN, Stock EG. Aripiprazole and perphenazine in severe treatment‐resistant schizophrenia. Proceedings of the 157th Annual Meeting of the American Psychiatric Association; 2004 May 1‐6; New York, USA. 2004.
Kane 2006 d {published and unpublished data}
    1. Kane JM, Swyzen W, Wu X, McQuade R, Gutierrez‐Esteinou R, Tran Q, Marcus R. Long‐term symptomatic remission in schizophrenia patients treated with aripiprazole or haloperidol. Proceedings of the 159th Annual Meeting of the American Psychiatric Association; 2006 May 20‐25, Toronto, Canada. 2006.
Kane 2007 a {published data only}
    1. Kane JM, Meltzer HY, Carson WH Jr, McQuade RD, Marcus RN, Sanchez R, Aripiprazole Study Group. Aripiprazole for treatment‐resistant schizophrenia: results of a multicenter, randomized, double‐blind, comparison study versus perphenazine. Journal of Clinical Psychiatry 2007;68(2):213‐23. - PubMed
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;Suppl 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.
    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.
Kim 2006 d {published data only}
    1. Kim JG, Cho DH, Lee SJ, Lee JK, Wang KS, Seo YI, Choi SJ, Joo MJ, Kim HD, Lee KH, Kwon YJ, Han KR. The comparison of efficacy between aripiprazole and haloperidol in treatment of chronic schizophrenia and schizoaffective disorder: results for 16‐week clinical study. Journal of the European College of Neuropsychopharmacology 2006;16(Suppl 4):S417.
Kujawa 2002 {published data only}
    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.
    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.
    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. - PubMed
    1. Kostic D, Manos G, Stock E, Jody D, Archibald D, Tourkodimitris S, Marcus R. Long‐term effects of aripiprazole on the negative symptoms of schizophrenia. Journal of the European College of Neuropsychopharmacology 2003;13(4):S328.
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.
    1. Kujawa MJ, Stringfellow J, Hardy S, Ali M, Marcus RN, Stock EG. The efficacy of aripiprazole in patients with schizoaffective disorder. Proceedings of the 156th Annual Meeting of the American Psychiatric Association; 2003 May 17‐22; San Francisco, USA. 2003.
Kujawa 2004 {published data only}
    1. Kujawa MJ, McQuade RD, Jody DN, Carson WH, Abou‐Gharbia N, Iwamoto T, Archibald DG, Stock EG. Long‐term weight effects of aripiprazole vs olanzapine in a 26‐week, double‐blind study. Proceedings of the XXIVth Collegium Internationale Neuro‐Psychopharmacologicum Congress; 2004 June 20–24, Paris, France 2004.
Liang 2005 {published data only}
    1. Liang J, Chen D. Aripiprazole and haloperidol in the treatment of schizophrenia. China Pharmaceuticals 2005;14(6):82.
Mai 2005 {published data only}
    1. Mai G‐Y, Cai G‐H, Huang J‐M. Comparative study on the effect of aripiprazole and risperidone on schizophrenia. Chinese Journal of Rehabilitation 2005;20(3):184‐5.
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. Effects of aripiprazole on excitement and hostility: Symptoms of schizophrenia. Proceedings of the 156th Annual Meeting of the American Psychiatric Association; 2003 17‐22 May; San Francisco, USA. 2003.
Marder 2004 {published data only}
    1. Marder SR, Archibald DG, Manos G, Stock EG, Jody DN, Tourkodimitris S, Marcus RN, Iwamoto T, Yamomoto Y, Carson WH. Long‐term effects of aripiprazole therapy on the negative symptoms of schizophrenia. Proceedings of the XXIVth Collegium Internationale Neuro‐Psychopharmacologicum Congress; 2004 June 20–24; Paris, France 2004.
McQuade 2002 {published data only}
    1. McQuade R, Carson W, Saha A, Ingenito G, Ali M, Archibald D. Aripiprazole for long‐term maintenance treatment of schizophrenia. Journal of the European College of Neuropsychopharmacology 2002;12(S3):S288. - PubMed
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. Proceedings of the Thematic Conference of the World Psychiatric Association on "Treatments in Psychiatry: An Update"; 2004 Nov 10‐13; Florence, Italy. 2004.
    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.
    1. McQuade RD, Jody DN, Kujawa MJ, Carson WH, Iwamoto T, Archibald DG, Stock EG. Long‐term weight effects of aripiprazole versus olanzapine. Proceedings of the 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. - PubMed
Modell 2005 b {published data only}
    1. Modell S, Jody D, Kujawa M, Carson W, Stringfellow J, Iwamoto T, Marcus R, Stock E T. Efficacy of aripiprazole and perphenazine in severe schizophrenia resistant to treatment with atypical antipsychotics. Journal of the European College of Neuropsychopharmacology 2004;14(Suppl 3):S265.
N0025078569 {published data only}
    1. N0025078569. A multi‐centre, d‐b, randomised comparative study of aripiprazole and olanzapine in the treatment of patients with acute schizophrenia. National Research Register 2001; Vol. 1.
Newcomer 2006 {unpublished data only}
    1. Newcomer JW, L'Italien G, Vester‐Blokland, McQuade RD, Carson WH, Marcus RN. Improvement of non‐HDL cholesterol levels among patients randomized to aripiprazole versus olanzapine. Proceedings of the 159th Annual Meeting of the American Psychiatric Association; 2006 May 20‐25, Toronto, Canada. 2006.
Octavio 2004 {published data only}
    1. Octavio I, Stock EG, Archibald DG, Tourkodimitris S, Kujawa MJ, Marcus R, Carson WH, Iwamoto T. Long‐term effects of aripiprazole on affective symptoms of schizophrenia. Proceedings of the XXIVth Collegium Internationale Neuro‐Psychopharmacologicum Congress; 2004 June 20–24 Paris, France 2004.
Octavio 2005 {published data only}
    1. Octavio I, Stock E, Archibald D, Tourkodimitris S, Kujawa M, Marcus R, Carson W, Iwamoto T. Long‐term effects of aripiprazole on affective symptoms of schizophrenia. Journal of the European College of Neuropsychopharmacology 2004;14(Suppl 3):S261.
Petrie 1997 {published and unpublished data}
    1. Petrie JL, Saha JR, McEvoy JP. Aripiprazole, a new typical antipsychotic: phase 2 clinical trial result. Proceedings of the 10th European College of Neuropsychopharmacology Congress; Sep 13‐17; Vienna, Austria. 1997.
Ray 2005 {published data only}
    1. Ray S, Corey‐Lisle PK, Cislo PR, L'Italien G, Weiden P. An economic evaluation of aripiprazole compared to olanzapine based on metabolic side‐effect profile. Journal of the European College of Neuropsychopharmacology 2004;14(Suppl 3):S279.
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. Proceedings of the Thematic Conference of the World Psychiatric Association on "Treatments in Psychiatry: An Update"; 2004 Nov 10‐13; Florence, Italy. 2004.
    1. McQuade RD. Investigator assessment of clinical parameters after initiating aripiprazole therapy. Proceedings of the 158th Anual Meeting of the American Psychiatric Association; 2005 May 21‐26; Atlanta, USA. 2005.
    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. Proceedings of the Thematic Conference of the World Psychiatric Association on "Treatments in Psychiatry: An Update"; 2004 Nov 10‐13; Florence, Italy. 2004.
    1. Riera L, Hu R, Stock E, Nyilas M, Torbeyns A, Borian F, Gentile K, Carson W, Iwamoto T. Broad effectivness trial with aripiprazole. Proceedings of the 157th Annual Meeting of the American Psychiatric Association; 2004 May 1‐6; New York, USA. 2004.
    1. Tandon R, Han J, Litalien G, Ray S, Carson Jr WH. Investigator's assessment questionnaire of antipsychotics' effectiveness. Proceedings of the 157th Annual Meeting of the American Psychiatric Association; 2004 May 1‐6; New York, USA. 2004.
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. Proceedings of the 12th Biennial Winter Workshop on Schizophrenia; 2004 Feb 7‐13; Davos, Switzwerland. 2004.
Sanchez 2006 {published data only}
    1. Sanchez R, Kostic D, Stock E, Torbeyns AF, Kerselaers W, Nyilas M, McQuade R, Carson WH, Marcus RN. Aripiprazole vs olanzapine in patients with acutely relapsing or chronic, stable schizophrenia: a 52‐week open‐label extension study. Proceedings of the 13th Biennial Winter Workshop on Schizophrenia Research; 2006 Feb 4‐10, Davos, Switzerland. 2006.
STAR 2006 {published and unpublished data}
    1. Corey‐Lisle P, Kolotkin RL, Crosby RD, L'Italien G. Changes in weight and weight‐related quality of life in aripiprazole versus standard‐of‐care treatment. Proceedings of the 14th Congress of the Association of European Psychiatrists; 2006 March 4‐8; Nice, France. 2006.
    1. Hanssens L, Biro E, Dillenschneider A, Spitzerova H, McQuade R, Iwamoto T. Reasons for participation and preference of medicine in community‐treated schizophrenic patients in a naturalistic setting (schizophrenia trial of aripiprazole: star study). Proceedings of the 14th Congress of the Association of European Psychiatrists; 2006 March 4‐8; Nice, France. 2006.
    1. Hanssens L, L'Italien G, Marcus RN, McQuade R, Carson WH, Beuzen JN. Effectiveness of aripiprazole versus olanzapine, quetiapine, or risperidone: sub‐analysis of a large, randomized, naturalistic study (STAR). Journal of the European College of Neuropsychopharmacology 2006;16(4):S421.
    1. Hanssens L, L'Italien G, Marcus RN, McQuade RD, Carson WH, Beuzen J‐N. Evaluation of quality of life in community‐treated schizophrenic patients: a naturalistic open‐label study comparing aripiprazole to standard‐of‐care. Proceedings of the 159th Annual Meeting of the American Psychiatric Association; 2006 May 20‐25, Toronto, Canada. 2006.
    1. Hanssens L, L'Italien G, Marcus RN, McQuade RD, Carson WH, Beuzen J‐N. Reasons for switching among community‐treated schizophrenic patients in a naturalistic setting : schizophrenia trial of aripiprazole: STAR study. Proceedings of the 159th Annual Meeting of the American Psychiatric Association; 2006 May 20‐25, Toronto, Canada. 2006.
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.
    1. Stock EG. Aripiprazole versus olanzapine in schizophrenia: A 52‐week, open‐label study. Proceedings of the 158th Annual Meeting of the American Psychiatric Association; 2005 May 21‐26; Atlanta, USA. 2005.
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. - PubMed
Tandon 2006 {published data only}
    1. Tandon R, Marcus RN, Stock EG, Riera LC, Kostic D, Pans M, McQuade RD, Nyilas M, Iwamoto T, Crandall DT. A prospective, multicenter, randomized, parallel‐group, open‐label study of aripiprazole in the management of patients with schizophrenia or schizoaffective disorder in general psychiatric practice: Broad Effectiveness Trial With Aripiprazole (BETA). Schizophrenia Research 2006;84(1):77‐89. - PubMed
Wang 2005 {published data only}
    1. Wang G‐P, Xie R, Pei G‐X. A comparative study between aripiprazole and chlorpromazine in the treatment of schizophrenia. Shandong Archives of Psychiatry 2005;18(4):250‐1.
Wang 2005 j {published data only}
    1. Wang R, Liu Y, Ning Z. A controlled study of aripiprazole vs clozapine in the treatment of first‐episode schizophrenia. Journal of Clinical Psychosomatic Diseases 2005;11(4):301‐2.
Wu 2005 d {published data only}
    1. Wu J‐D, Li Y‐D, Song Z‐W. Effect of aripiprazole or haldol on intelligence and memory in the first‐onset schizophrenia. Chinese Journal of Rehabilitation Theory and Practice 2006;12(1):64‐5.
Xia 2005 {published data only}
    1. Xia S‐Y, Hua P, Nie Y‐B. A treatment study of schizophrenia with aripiprazole and chlorpromazine. Practical Clinical Medicine 2005;6(10):33‐4.
Ye 2005 {published data only}
    1. Ye X‐R, Xia X‐L. A comparative study between aripiprazole and risperidone in treatment of first‐onset schizophrenia. Medical Journal of National Defending Forces in Southwest China 2005;15(6):616‐8.
Zhang 2005 {published data only}
    1. Zhang Y, Gu Z, Sun A. Aripiprazole on the quality of life of patients with schizophrenia. Journal of Jining Medical College 2005;28(4):50‐1.
Zhang 2005 a {published data only}
    1. Zhang Y, Liu X, Li X‐Y, Wang W. Aripiprazole and risperidone in the treatment of schizophrenia. Chinese Journal of Behavioural Medical Sciences 2005;14(10):923‐5.
Zhao 2005 {published data only}
    1. Zhao Z‐Z, Li X‐L, Zou Z‐M. A comparative study on aripiprazole and sulpiride in treating schizophrenia whose predominant clinical features were negative symptoms. Medical Journal of Chinese People Health 2005;17(12):728‐30.
Zhi 2005 {published data only}
    1. Zhi S‐L. Comparison study of aripiprazole and risperidone on schizophrenia. Modern Journal of Integrated Traditional Chinese and Western Medicine 2005;14(21):2787‐8.
Zhu 2005 {published data only}
    1. Zhu L, Wu H, Huang S, Liu X‐X. Aripiprazole and risperidone in the treatment of schizophrenia‐control study. Nervous Diseases and Mental Hygiene 2005;5(4):282.
Zhu 2005 a {published data only}
    1. Zhu P‐J, Cheng Z‐E, Zhang J, Zhu P‐L, Zhan X‐M. Clinical study of therapeutic effects of aripiprazole in treatment of patients with schizophrenia. Chinese Journal of Clinical Pharmacology and Therapeutics 2005;10(10):1194‐7.
Zhu 2005 b {published data only}
    1. Zhu L, Wu H, Huang S, Liu X‐X. Aripiprazole and risperidone in the treatment of schizophrenia. Shanghai Medical and Pharmaceutical Journal 2005;26(9):425‐6.

References to studies awaiting assessment

Carson 2008 {published and unpublished data}
    1. Carson WH, Nyilas M, Forbes RA, Pikalov A, McQuade RD, Ivanova S, Owen R, Ginsberg L, Wagner KD. Acute efficacy of aripripazole for the treatment of bipolar 1 disorder in paediatric patients. Schizophrenia Research 2008;98:42.
Nyilas 2007 {unpublished data only}
    1. Nyilas M, Findling RL, Johnson B, Forbes RA, Pikalov A, Marcus R, Carson WH, Robb A. Proceedings of the 46th Annual Meeting of the American College of Neuropsychopharmacology; 2007 Dec 9‐13; Florida, USA. 2007.

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