Joseph R Calabrese 1,2 , Raymond Sanchez 3 , Na Jin 3 , Joan Amatniek 3 , Kevin Cox 3 , Brian Johnson 3 , Pamela Perry 3 , Peter Hertel 4 , Pedro Such 4 , Phyllis M Salzman 3 , Robert D McQuade 3 , Margaretta Nyilas 3 , William H Carson 3 Show Affiliations »
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OBJECTIVE: To evaluate efficacy, safety, and tolerability of long-acting injectable antipsychotic aripiprazole once-monthly 400 mg (AOM 400) as maintenance treatment for bipolar I disorder (BP-I). METHODS: In a double-blind, placebo -controlled, 52-week randomized withdrawal study conducted from August 2012 to April 2016, patients with a DSM-IV-TR diagnosis of BP-I currently experiencing a manic episode were stabilized sequentially on oral aripiprazole and AOM 400 and then randomized to AOM 400 or placebo . The primary end point was time from randomization to recurrence of any mood episode . Other end points included proportion of patients with recurrence of any mood episode and recurrence by mood episode type . RESULTS: Of 266 randomized patients, 64 (48.1%) of 133 in the AOM 400 group and 38 (28.6%) of 133 in the placebo group completed the study. AOM 400 significantly delayed the time to recurrence of any mood episode compared with placebo (hazard ratio: 0.45; 95% CI, 0.30 to 0.68; P < .0001). Significantly fewer patients (P < .0001) experienced recurrence of any mood episode with AOM 400 (35/132; 26.5%) compared with placebo (68/133; 51.1%), with the effects observed predominantly on manic episodes (P < .0001). Patients were not depressed at study entry, and between-group differences in depressive episodes were not significant (P < .864). The treatment-emergent adverse events (incidence > 5%) that were reported at higher rates with AOM 400 than placebo were weight increase, akathisia, insomnia, and anxiety . CONCLUSIONS: AOM 400 delayed the time to and reduced the rate of recurrence of mood episodes and was generally safe and well tolerated . These findings support the use of AOM 400 for maintenance treatment of BP-I. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01567527. © Copyright 2017 Physicians Postgraduate Press, Inc.
RCT Entities: Population
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OBJECTIVE: To evaluate efficacy, safety, and tolerability of long-acting injectable antipsychotic aripiprazole once-monthly 400 mg (AOM 400) as maintenance treatment for bipolar I disorder (BP -I ). METHODS: In a double-blind, placebo-controlled, 52-week randomized withdrawal study conducted from August 2012 to April 2016, patients with a DSM-IV-TR diagnosis of BP -I currently experiencing a manic episode were stabilized sequentially on oral aripiprazole and AOM 400 and then randomized to AOM 400 or placebo. The primary end point was time from randomization to recurrence of any mood episode. Other end points included proportion of patients with recurrence of any mood episode and recurrence by mood episode type. RESULTS: Of 266 randomized patients , 64 (48.1%) of 133 in the AOM 400 group and 38 (28.6%) of 133 in the placebo group completed the study. AOM 400 significantly delayed the time to recurrence of any mood episode compared with placebo (hazard ratio: 0.45; 95% CI, 0.30 to 0.68; P < .0001). Significantly fewer patients (P < .0001) experienced recurrence of any mood episode with AOM 400 (35/132; 26.5%) compared with placebo (68/133; 51.1%), with the effects observed predominantly on manic episodes (P < .0001). Patients were not depressed at study entry, and between-group differences in depressive episodes were not significant (P < .864). The treatment-emergent adverse events (incidence > 5%) that were reported at higher rates with AOM 400 than placebo were weight increase, akathisia , insomnia , and anxiety . CONCLUSIONS: AOM 400 delayed the time to and reduced the rate of recurrence of mood episodes and was generally safe and well tolerated. These findings support the use of AOM 400 for maintenance treatment of BP -I . TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01567527. © Copyright 2017 Physicians Postgraduate Press, Inc.
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Year: 2017
PMID： 28146613 DOI： 10.4088/JCP.16m11201
Source DB: PubMed Journal: J Clin Psychiatry ISSN： 0160-6689 Impact factor: 4.384