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NCT01567527 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 731
- Enrollment target
NCT01567527 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 731 participants.
The verdict
NCT01567527, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 731 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Intramuscular (IM) Depot Aripiprazole
- DRUG Intramuscular (IM) Depot Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 731 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01567527
The ClinicalTrials.gov registry entry for NCT01567527 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 731 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intramuscular (IM) Depot Aripiprazole is the first listed.
NCT01567527 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01567527 about?
NCT01567527 is a clinical study titled "Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients". 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 a...
What is the current status of trial NCT01567527?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 731 participants. The study started on 2012-08. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01567527?
The interventions under investigation include: Intramuscular (IM) Depot Aripiprazole (DRUG), Intramuscular (IM) Depot Placebo (DRUG).
Who is sponsoring clinical trial NCT01567527?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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