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Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study.
J Clin Psychiatry. 2012 May; 73(5):617-24.JC

Abstract

OBJECTIVE

To evaluate the efficacy and tolerability of a once-monthly intramuscular (IM) depot formulation of the dopamine partial agonist aripiprazole as maintenance treatment in adults meeting DSM-IV-TR schizophrenia criteria.

METHOD

The study was conducted from July 2008 until February 2011. Subjects requiring chronic treatment with an antipsychotic entered a 4- to 12-week oral stabilization phase and received oral aripiprazole (10-30 mg/d). Subjects meeting stability criteria for 4 weeks entered an IM-depot stabilization phase in which they received 400-mg aripiprazole-IM-depot injections every 4 weeks (single decrease to 300 mg permitted) with coadministration of oral aripiprazole tablets in the first 2 weeks. Subjects meeting stability criteria for 12 consecutive weeks were randomly assigned (2:1) to aripiprazole-IM-depot or placebo during a 52-week, double-blind maintenance phase. The primary outcome measure was time to exacerbation of psychotic symptoms/impending relapse (event). Safety and tolerability were also assessed.

RESULTS

710 patients entered oral stabilization, 576 progressed to IM-depot stabilization, and 403 were randomly assigned to double-blind treatment. The study was terminated early because efficacy was demonstrated by the preplanned interim analysis (conducted after 64 events). Time to impending relapse was significantly delayed with aripiprazole-IM-depot treatment compared with placebo in both the interim analysis and the final analysis (P < .0001, log-rank test). The hazard ratio (placebo/aripiprazole-IM-depot) at final analysis was 5.03 (95% CI, 3.15-8.02). The rate of impending relapse was significantly lower with aripiprazole-IM-depot than placebo at endpoint (final analysis, 10.0% [n = 27/269] vs 39.6% [n = 53/134]). Improvements in Clinical Global Impressions-Severity of Illness scale and Positive and Negative Syndrome Scale total scores were maintained with aripiprazole-IM-depot treatment but showed significant worsening with placebo (change from double-blind baseline, P < .0001 for aripiprazole-IM-depot vs placebo). The most common treatment-emergent adverse events (occurring in ≥ 5% of aripiprazole-IM-depot subjects and greater than placebo) were insomnia, tremor, and headache.

CONCLUSIONS

Aripiprazole-IM-depot significantly delayed time to impending relapse compared with placebo and appears to be a well-tolerated maintenance treatment option for schizophrenia.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT00705783.

Authors+Show Affiliations

The Zucker Hillside Hospital and The Hofstra North Shore-LIJ School of Medicine, Glen Oaks, NY 11004-1100, USA. psychiatry@nshs.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22697189

Citation

Kane, John M., et al. "Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia: a 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study." The Journal of Clinical Psychiatry, vol. 73, no. 5, 2012, pp. 617-24.
Kane JM, Sanchez R, Perry PP, et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012;73(5):617-24.
Kane, J. M., Sanchez, R., Perry, P. P., Jin, N., Johnson, B. R., Forbes, R. A., McQuade, R. D., Carson, W. H., & Fleischhacker, W. W. (2012). Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. The Journal of Clinical Psychiatry, 73(5), 617-24. https://doi.org/10.4088/JCP.11m07530
Kane JM, et al. Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia: a 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study. J Clin Psychiatry. 2012;73(5):617-24. PubMed PMID: 22697189.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. AU - Kane,John M, AU - Sanchez,Raymond, AU - Perry,Pamela P, AU - Jin,Na, AU - Johnson,Brian R, AU - Forbes,Robert A, AU - McQuade,Robert D, AU - Carson,William H, AU - Fleischhacker,W Wolfgang, PY - 2011/11/10/received PY - 2012/02/14/accepted PY - 2012/6/16/entrez PY - 2012/6/16/pubmed PY - 2012/8/30/medline SP - 617 EP - 24 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 73 IS - 5 N2 - OBJECTIVE: To evaluate the efficacy and tolerability of a once-monthly intramuscular (IM) depot formulation of the dopamine partial agonist aripiprazole as maintenance treatment in adults meeting DSM-IV-TR schizophrenia criteria. METHOD: The study was conducted from July 2008 until February 2011. Subjects requiring chronic treatment with an antipsychotic entered a 4- to 12-week oral stabilization phase and received oral aripiprazole (10-30 mg/d). Subjects meeting stability criteria for 4 weeks entered an IM-depot stabilization phase in which they received 400-mg aripiprazole-IM-depot injections every 4 weeks (single decrease to 300 mg permitted) with coadministration of oral aripiprazole tablets in the first 2 weeks. Subjects meeting stability criteria for 12 consecutive weeks were randomly assigned (2:1) to aripiprazole-IM-depot or placebo during a 52-week, double-blind maintenance phase. The primary outcome measure was time to exacerbation of psychotic symptoms/impending relapse (event). Safety and tolerability were also assessed. RESULTS: 710 patients entered oral stabilization, 576 progressed to IM-depot stabilization, and 403 were randomly assigned to double-blind treatment. The study was terminated early because efficacy was demonstrated by the preplanned interim analysis (conducted after 64 events). Time to impending relapse was significantly delayed with aripiprazole-IM-depot treatment compared with placebo in both the interim analysis and the final analysis (P < .0001, log-rank test). The hazard ratio (placebo/aripiprazole-IM-depot) at final analysis was 5.03 (95% CI, 3.15-8.02). The rate of impending relapse was significantly lower with aripiprazole-IM-depot than placebo at endpoint (final analysis, 10.0% [n = 27/269] vs 39.6% [n = 53/134]). Improvements in Clinical Global Impressions-Severity of Illness scale and Positive and Negative Syndrome Scale total scores were maintained with aripiprazole-IM-depot treatment but showed significant worsening with placebo (change from double-blind baseline, P < .0001 for aripiprazole-IM-depot vs placebo). The most common treatment-emergent adverse events (occurring in ≥ 5% of aripiprazole-IM-depot subjects and greater than placebo) were insomnia, tremor, and headache. CONCLUSIONS: Aripiprazole-IM-depot significantly delayed time to impending relapse compared with placebo and appears to be a well-tolerated maintenance treatment option for schizophrenia. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00705783. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/22697189/Aripiprazole_intramuscular_depot_as_maintenance_treatment_in_patients_with_schizophrenia:_a_52_week_multicenter_randomized_double_blind_placebo_controlled_study_ L2 - http://www.psychiatrist.com/jcp/article/pages/2012/v73n05/v73n0508.aspx DB - PRIME DP - Unbound Medicine ER -