Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Public ClinicalTrials.gov record NCT00706654. 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
A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.
Study identification
- NCT ID
- NCT00706654
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 937 participants
Conditions and interventions
Conditions
Interventions
- Aripiprazole depot 300 or 400 mg Drug
- Aripiprazole 10-30 mg orally Drug
- Aripiprazole depot 25 or 50 mg Drug
- Placebo depot Drug
- Placebo tablets Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 60 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
- Sep 1, 2008 (Actual)
- Primary completion
- Aug 1, 2012 (Actual)
- Completion
- Aug 1, 2012 (Actual)
- Last update posted
- Jun 4, 2026
2008 – 2012
United States locations
- U.S. sites
- 39
- U.S. states
- 16
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Cerritos | California | 90703 | — |
| Not listed | Escondido | California | 92025 | — |
| Not listed | Garden Grove | California | 92845 | — |
| Not listed | Oceanside | California | 92056 | — |
| Not listed | Orange | California | 92868-3298 | — |
| Not listed | Orange | California | 92868 | — |
| Not listed | Pasadena | California | 91106 | — |
| Not listed | Pico Rivera | California | 90660 | — |
| Not listed | San Diego | California | 92102 | — |
| Not listed | San Diego | California | 92103-8620 | — |
| Not listed | San Diego | California | 92123 | — |
| Not listed | Torrance | California | 90502 | — |
| Not listed | Washington D.C. | District of Columbia | 20016 | — |
| Not listed | Gainesville | Florida | 32608 | — |
| Not listed | Kissimmee | Florida | 34741 | — |
| Not listed | Plantation | Florida | 33317 | — |
| Not listed | Tampa | Florida | 33613 | — |
| Not listed | Chicago | Illinois | 60612 | — |
| Not listed | Oak Brook | Illinois | 60523 | — |
| Not listed | Shreveport | Louisiana | 71104 | — |
| Not listed | Towson | Maryland | 21286 | — |
| Not listed | Kansas City | Missouri | 64108 | — |
| Not listed | Buffalo | New York | 14213 | — |
| Not listed | New York | New York | 10003 | — |
| Not listed | New York | New York | 10035 | — |
| Not listed | Rochester | New York | 14624 | — |
| Not listed | Hickory | North Carolina | 28601 | — |
| Not listed | South Carolina | North Carolina | 29425 | — |
| Not listed | Garfield Heights | Ohio | 44125 | — |
| Not listed | Toledo | Ohio | 43609 | — |
| Not listed | Oklahoma City | Oklahoma | 73112 | — |
| Not listed | Charleston | South Carolina | 29401 | — |
| Not listed | Charleston | South Carolina | 29407 | — |
| Not listed | Johnson City | Tennessee | 37614-1707 | — |
| Not listed | Nashville | Tennessee | 37212 | — |
| Not listed | Arlington | Texas | 76011 | — |
| Not listed | Austin | Texas | 78756 | — |
| Not listed | Richmond | Virginia | 23230 | — |
| Not listed | Milwaukee | Wisconsin | 53226 | — |
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 59 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00706654, 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 Jun 4, 2026 · Synced Nov 1, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00706654 live on ClinicalTrials.gov.