Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients
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|ClinicalTrials.gov Identifier: NCT01567527|
Recruitment Status : Completed
First Posted : March 30, 2012
Results First Posted : August 24, 2018
Last Update Posted : August 24, 2018
This will be a randomized, double-blind, placebo-controlled trial to assess the time to recurrence of any mood episode in subjects with bipolar I disorder who have maintained stability on aripiprazole IM depot for at least 8 weeks. This trial will include male and female subjects 18 to 65 years of age, inclusive, with a diagnosis of bipolar I disorder, according to DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI), who have experienced at least one previous manic episode of sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic agent in addition to their current manic episode. All subjects must be experiencing a manic episode (per DSM-IV-TR criteria) with a YMRS total score ≥ 20 at trial entry. Both inpatients and outpatients are eligible for this trial.
This trial will consist of a screening phase followed by 4 treatment phases. Subjects will undergo screening for eligibility, followed by a conversion to oral aripiprazole monotherapy phase, if needed, an oral aripiprazole stabilization phase, a single-blind aripiprazole IM depot stabilization phase, and, a double-blind, placebo-controlled phase.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar I Disorder||Drug: Intramuscular (IM) Depot Aripiprazole Drug: Intramuscular (IM) Depot Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||731 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Active Comparator: 1
Active Comparator: Treatment of Aripiprazole IM Depot
Drug: Intramuscular (IM) Depot Aripiprazole
Formulation: Intramuscular (IM) Depot Aripiprazole Formulation 400 mg or 300 mg, once a month injection
Placebo Comparator: 2
Placebo Comparator: Treatment of IM Depot Placebo
Drug: Intramuscular (IM) Depot Placebo
Formulation: Intramuscular (IM) Depot Placebo 400 mg or 300 mg, once a month injection
- Time From Randomization to Recurrence of Any Mood Episode During Double-bind Placebo-controlled Phase. [ Time Frame: Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52). ]
This endpoint was defined as meeting any of the following criteria:
- Hospitalization for any mood episode OR
Any of the following:
- YMRS total score ≥ 15 OR
- MADRS total score ≥ 15 OR
- CGI-BP-S score > 4 (overall score) OR
- SAE of worsening disease (bipolar I disorder) OR
- Discontinuation due to lack of efficacy or discontinuation due to an AE of worsening disease OR
- Clinical worsening with the need for treatment of symptoms of an underlying mood disorder by addition of a mood stabilizer, antidepressant treatment, antipsychotic medication, or increase greater than the allowed benzodiazepine doses, or
- Active suicidality, which is defined as a score of 4 or more on the MADRS item 10 OR an answer of "yes" on question 4 or 5 on the C-SSRS.
The time to event is presented in the following table.
- Number of Subjects Meeting Criteria for Recurrence of Any Mood Episode. [ Time Frame: Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52). ]To assess the proportion of subjects who met criteria for recurrence of any mood episode (manic, mixed or depressive). Hierarchical procedure was used to preserve the overall Type I error at 0.05.
- Mean Change From Randomization to Endpoint in the CGI-BP-S (Mania) Score. [ Time Frame: Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52). ]CGI-BP-S assessed the subject's severity of Illness (mania) based on a 7-point scale ranging from 1 (normal/ not ill at all) to 7 (very severely ill).
- Time From Randomization to Recurrence Defined by Hospitalization for a Mood Episode. [ Time Frame: Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52). ]
Analysis of time from randomization to recurrence defined by hospitalization for a mood episode (Double-blind, Placebo-controlled Phase efficacy sample).
Time to recurrence is presented in the following table.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567527
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|Study Director:||Stacy Wu, MD||Otsuka Pharmaceutical Development and Commercialization, Inc.|