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Aripiprazole monotherapy in patients with rapid-cycling bipolar I disorder: an analysis from a long-term, double-blind, placebo-controlled study.

ABSTRACT: Rapid-cycling bipolar disorder is difficult to treat and associated with greater morbidity than non-rapid-cycling disease. This post hoc analysis evaluated 28 patients with rapid-cycling bipolar I disorder from a 100-week, double-blind, placebo-controlled study assessing long-term efficacy, safety and tolerability of aripiprazole in patients with bipolar I disorder (most recently manic/mixed).Following >or= 6 consecutive weeks' stabilisation with open-label aripiprazole, patients were randomised (1 : 1) to aripiprazole or placebo. Patients completing 26 weeks treatment without relapse could continue for a further 74 weeks. Primary end-point was time to relapse for manic, mixed or depressive symptoms, defined as discontinuation due to lack of efficacy. Safety assessments included adverse event (AE) monitoring and changes in weight and lipid, glucose and prolactin levels.Of the 28 patients (aripiprazole, n = 14; placebo, n = 14) with rapid-cycling bipolar disorder, 12 (aripiprazole, n = 7; placebo, n = 5) completed the initial 26-week treatment period and three (all aripiprazole treated) completed the 100-week, double-blind period. Time to relapse was significantly longer with aripiprazole vs. placebo at week 26 [log-rank p = 0.033; 26-week hazard ratio = 0.21 (95% CI: 0.04, 1.03)] and week 100 [log-rank p = 0.017; 100-week hazard ratio = 0.18 (95% CI: 0.04, 0.88)]. The most commonly reported AEs with aripiprazole during the 100 weeks (>or= 10% incidence and twice placebo) were anxiety (n = 4), sinusitis (n = 4), depression (n = 3) and upper respiratory infection (n = 3). One aripiprazole-treated patient discontinued due to an AE (akathisia). There were no significant between-group differences in mean changes in weight or metabolic parameters.In this small, post hoc subanalysis, aripiprazole maintained efficacy and was generally well tolerated in the long-term treatment of rapid-cycling bipolar disorder. Further research with prospectively designed and adequately powered trials is warranted.

SUBMITTER: Muzina DJ

PROVIDER: S-EPMC2324208 | biostudies-literature | 2008 May

REPOSITORIES: biostudies-literature

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Aripiprazole monotherapy in patients with rapid-cycling bipolar I disorder: an analysis from a long-term, double-blind, placebo-controlled study.

Muzina D J DJ Momah C C Eudicone J M JM Pikalov A A McQuade R D RD Marcus R N RN Sanchez R R Carlson B X BX

International journal of clinical practice 20080325 5

<h4>Aims</h4>Rapid-cycling bipolar disorder is difficult to treat and associated with greater morbidity than non-rapid-cycling disease. This post hoc analysis evaluated 28 patients with rapid-cycling bipolar I disorder from a 100-week, double-blind, placebo-controlled study assessing long-term efficacy, safety and tolerability of aripiprazole in patients with bipolar I disorder (most recently manic/mixed).<h4>Methods</h4>Following >or= 6 consecutive weeks' stabilisation with open-label aripipraz ...[more]

PMID: 18373615

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Project description:Metabolic risk factors, termed metabolic syndrome, which include obesity, diabetes, dyslipidemia, and hypertension, are more common in patients with bipolar disorder than in the general population. Moreover, medications used to treat bipolar disorder carry some risk of worsening metabolic parameters.The study was conducted at 46 study centers in the United States, although only 31 study centers enrolled patients in the 40-week extension phase. Patients with acute bipolar I mania, manic or mixed (DSM-IV-TR criteria; Young Mania Rating Scale score ? 20), who required hospitalization were randomly assigned to double-blind aripiprazole (15-30 mg/d), lithium (900-1500 mg/d), or placebo for 3 weeks. Patients treated with aripiprazole or lithium continued treatment to week 12, after which they could enter a double-blind 40-week extension phase. Patients were enrolled in the 12-week acute treatment phase between April 2004 and July 2006; the first patient entered extension treatment in October 2004, and the last patient completed treatment in May 2007. Changes in metabolic parameters were compared between patients treated with aripiprazole or lithium for up to 52 weeks using last observation carried forward and analysis of covariance. Analysis stratified by baseline body mass index (BMI) was also conducted.Modest increases in body weight were observed in both groups: +0.97 kg (2.1 lb) for aripiprazole (n = 127) and + 0.74 (1.6 lb) for lithium (n = 136), P = .60. A significant difference in body weight increase was observed only among patients with a BMI < 25: + 2.66 kg (5.9 lb) for aripiprazole (n = 35) and + 0.40 kg (0.9 lb) for lithium (n = 37), P = .02. Mean changes from baseline to week 52 in fasting levels of total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, plasma glucose, triglycerides, or insulin (last observation carried forward) were small in both aripiprazole and lithium treatment groups; no significant differences were observed. Mean laboratory values were within the normal or borderline range for both treatment groups across all BMI categories.Comparably modest and similar changes in metabolic parameters were observed in patients with bipolar disorder treated for up to 1 year with either lithium or aripiprazole.clinicaltrials.gov Identifier: NCT00095511.

Dataset Information

Aripiprazole monotherapy in patients with rapid-cycling bipolar I disorder: an analysis from a long-term, double-blind, placebo-controlled study.

Publications

Aripiprazole monotherapy in patients with rapid-cycling bipolar I disorder: an analysis from a long-term, double-blind, placebo-controlled study.

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