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
Study identification
- NCT ID
- NCT01567527
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Industry
- Enrollment
- 731 participants
Conditions and interventions
Conditions
Interventions
- Intramuscular (IM) Depot Aripiprazole Drug
- Intramuscular (IM) Depot Placebo Drug
Drug
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
- Jul 31, 2012
- Primary completion
- Mar 31, 2016
- Completion
- Mar 31, 2016
- Last update posted
- Aug 23, 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 23, 2018 · Synced Jul 22, 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 protocol, eligibility criteria, and contact information for NCT01567527 live on ClinicalTrials.gov.