Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Public ClinicalTrials.gov record NCT00705783. 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 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia. The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient to be converted from their current antipsychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2, the patient was stabilized on oral non-generic aripiprazole monotherapy (oral stabilization phase from a minimum of 4 weeks to a maximum of 12 weeks). Once the patient was stabilized in Phase 2, they entered Phase 3, the single-blind intramuscular (IM) depot aripiprazole stabilization phase. The goal of the phase was to stabilize the patient on the IM depot aripiprazole formulation for a minimum of 12 weeks to a maximum of 36 weeks. When the patient was stabilized, they were eligible to be randomized into the double-blind IM depot maintenance phase (Phase 4). During Phase 4, the patient was assessed for exacerbation of psychotic symptoms and/or impending relapse for up to 52 weeks.
Study identification
- NCT ID
- NCT00705783
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 843 participants
Conditions and interventions
Conditions
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
- Jul 2008 (Type not available)
- Primary completion
- Aug 2010 (Actual)
- Completion
- Feb 2011 (Actual)
- Last update posted
- Jul 19, 2013
2008 – 2011
United States locations
- U.S. sites
- 43
- U.S. states
- 21
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Otsuka Investigational Site | Chandler | Arizona | 85226 | — |
| Otsuka Investigational Site | Anaheim | California | 92805 | — |
| Otsuka Investigational Site | National City | California | 91950 | — |
| Otsuka Investigational Site | Oceanside | California | 92056 | — |
| Otsuka Investigational Site | San Diego | California | 92123 | — |
| Otsuka Investigational Site | Santa Ana | California | 92701 | — |
| Otsuka Investigational Site | Highlands Ranch | Colorado | 80130 | — |
| Otsuka Investigational Site | Norwalk | Connecticut | 06851 | — |
| Otsuka Investigational Site | Altamonte Springs | Florida | 32701 | — |
| Otsuka Investigational Site | Bradenton | Florida | 34208 | — |
| Otsuka Investigational Site | Hollywood | Florida | 33021 | — |
| Otsuka Investigational Site | Maitland | Florida | 32751 | — |
| Otsuka Investigational Site | Miami | Florida | 33135 | — |
| Otsuka Investigational Site | North Miami | Florida | 33161 | — |
| Otsuka Investigational Site | Orange City | Florida | 32763 | — |
| Otsuka Investigational Site | Tampa | Florida | 33613 | — |
| Otsuka Investigational Site | Atlanta | Georgia | 30328 | — |
| Otsuka Investigational Site | Hoffman Estates | Illinois | 60169 | — |
| Otsuka Investigational Site | Munster | Indiana | 46321 | — |
| Otsuka Investigational Site | Baton Rouge | Louisiana | 70808 | — |
| Otsuka Investigational Site | Baton Rouge | Louisiana | 70809 | — |
| Otsuka Investigational Site | Lake Charles | Louisiana | 70601 | — |
| Otsuka Investigational Site | New Orleans | Louisiana | 70115 | — |
| Otsuka Investigational Site | Columbia | Maryland | 21045 | — |
| Otsuka Investigational Site | Flowood | Mississippi | 39232 | — |
| Otsuka Investigational Site | St Louis | Missouri | 63118 | — |
| Otsuka Investigational Site | North Platte | Nebraska | 69101 | — |
| Otsuka Investigational Site | Albuquerque | New Mexico | 87131 | — |
| Otsuka Investigational Site | Buffalo | New York | 14215 | — |
| Otsuka Investigational Site | Cedarhurst | New York | 11516 | — |
| Otsuka Investigational Site | Elmsford | New York | 10523 | — |
| Otsuka Investigational Site | Holliswood | New York | 11423 | — |
| Otsuka Investigational Site | Jamaica | New York | 11418 | — |
| Otsuka Investigational Site | Staten Island | New York | 10305 | — |
| Otsuka Investigational Site | Cleveland | Ohio | 44109 | — |
| Otsuka Investigational Site | Oklahoma City | Oklahoma | 73103 | — |
| Otsuka Investigational Site | Philadelphia | Pennsylvania | 19131 | — |
| Otsuka Investigational Site | Memphis | Tennessee | 38119 | — |
| Otsuka Investigational Site | Austin | Texas | 78754 | — |
| Otsuka Investigational Site | DeSoto | Texas | 75115 | — |
| Otsuka Investigational Site | Bellevue | Washington | 98007 | — |
| Otsuka Investigational Site | Bothell | Washington | 98011 | — |
| Otsuka Investigational Site | Richland | Washington | 99354 | — |
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 67 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00705783, 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 Jul 19, 2013 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00705783 live on ClinicalTrials.gov.