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52-WEEK MAINTENANCE STUDY
Study design
52-week multiphase maintenance study of patients with bipolar I disorder with a history of ≥1 manic or mixed episode that required hospitalization, or treatment with either a mood stabilizer or antipsychotic. Baseline patient characteristics included patients currently experiencing a manic episode and ≥20 YMRS total score; patients were excluded if they experienced ≥9 episodes (rapid cycling) in the past year.1
Phases consisted of an open-label phase 1 (conversion to oral aripiprazole), an open-label phase 2 (stabilization on oral aripiprazole 15 mg to 30 mg once daily), a single-blind phase 3 (conversion and stabilization on ABILIFY MAINTENA 400 mg; patients continued on oral aripiprazole 10 mg to 20 mg for the first 14 days following the initial ABILIFY MAINTENA dose), and a double-blind, placebo-controlled, randomized phase 4 in which patients received either ABILIFY MAINTENA (n=133) or placebo IM depot (n=133).1
IM=intramuscular; YMRS=Young Mania Rating Scale.
ABILIFY MAINTENA significantly delayed time to recurrence‡ of any mood episode vs placebo (HR=0.45 [95% CI, 0.30-0.68], P<0.0001)1§
Primary endpoint: Time from randomization to recurrence‡ of any mood episode1
Significantly delayed time to recurrence for a manic episode and mixed episode. No substantial difference in the time to a depressive episode.
‡Recurrence was defined as clinical worsening, psychiatric hospitalization, or increased risk of suicide.
§This figure is based on a total of 103 recurrences.
CI=confidence interval; HR=hazard ratio.
Important Warning and Precaution Regarding Cerebrovascular Adverse Events, Including Stroke
Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with oral aripiprazole.
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Secondary endpoint: RecurrenceII of manic or mixed episode2
REDUCED RISK OF RECURRENCE OF MANIC OR MIXED MOOD EPISODES vs PLACEBO (HR=0.249 [95% CI, 0.137-0.451], P<0.0001)2
- Significantly delayed time to recurrence for a manic episode (HR=0.259 [95% CI, 0.136-0.495], P<0.0001) or mixed episode (HR=0.202 [95% CI, 0.044-0.939], P=0.0237)2
- No substantial difference in the time to a depressive episode (HR=0.932 [95% CI, 0.497-1.747], P=0.8247)2
The HR was used to calculate the reduction in risk of recurrence for patients on ABILIFY MAINTENA vs placebo.
||Recurrence was defined as clinical worsening, psychiatric hospitalization, or increased risk of suicide.
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Important Warning and Precaution Regarding Neuroleptic Malignant Syndrome (NMS)
NMS is a potentially fatal symptom complex reported in association with administration of antipsychotic drugs including ABILIFY MAINTENA. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of ABILIFY MAINTENA, intensive symptomatic treatment, and monitoring.
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Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.
References: 1. Calabrese JR, Sanchez R, Jin N, et al. Efficacy and safety of aripiprazole once-monthly in the maintenance treatment of bipolar I disorder: a double-blind, placebo-controlled, 52-week randomized withdrawal study. J Clin Psychiatry. 2017;78(3):324-331. 2. Data on file. ABIMAI-178.