Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients
Public ClinicalTrials.gov record NCT01567527. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01567527
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 731 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2012 (Type not available)
- Primary completion
- Apr 2016 (Actual)
- Completion
- Apr 2016 (Actual)
- Last update posted
- Aug 24, 2018
2012 – 2016
United States locations
- U.S. sites
- 42
- U.S. states
- 18
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Springdale | Arkansas | — | — |
| Not listed | Beverly Hills | California | — | — |
| Not listed | Costa Mesa | California | — | — |
| Not listed | Escondido | California | — | — |
| Not listed | Garden Grove | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | National City | California | — | — |
| Not listed | Oceanside | California | — | — |
| Not listed | Orange | California | — | — |
| Not listed | Pico Rivera | California | — | — |
| Not listed | Riverside | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Temecula | California | — | — |
| Not listed | Torrance | California | — | — |
| Not listed | Lauderhill | Florida | — | — |
| Not listed | Leesburg | Florida | — | — |
| Not listed | Melbourne | Florida | — | — |
| Not listed | Oakland Park | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Decatur | Georgia | — | — |
| Not listed | Smyrna | Georgia | — | — |
| Not listed | Hoffman Estates | Illinois | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Rockville | Maryland | — | — |
| Not listed | Flowood | Mississippi | — | — |
| Not listed | Saint Charles | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Lincoln | Nebraska | — | — |
| Not listed | Cherry Hill | New Jersey | — | — |
| Not listed | Brooklyn | New York | — | — |
| Not listed | Buffalo | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Dayton | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Allentown | Pennsylvania | — | — |
| Not listed | Jenkintown | Pennsylvania | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Wichita Falls | Texas | — | — |
| Not listed | Richmond | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01567527, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2018 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01567527 live on ClinicalTrials.gov.