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Completed Phase 3 Interventional Results available

Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia

ClinicalTrials.gov ID: NCT01683058

Public ClinicalTrials.gov record NCT01683058. 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.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 5:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297) will allow the subjects who complete Trial 291 to enter this open label trial at the investigator's discretion, where additional safety and tolerability data will be collected.

Study identification

NCT ID
NCT01683058
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
74 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 66 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
Dec 31, 2012
Primary completion
Jan 31, 2014
Completion
Jan 31, 2014
Last update posted
Mar 30, 2015

2013 – 2014

United States locations

U.S. sites
35
U.S. states
14
U.S. cities
29
Facility City State ZIP Site status
Not listed Little Rock Arkansas 72201
Not listed Springdale Arkansas 72764
Not listed Carson California 90746
Not listed Escondido California 92025
Not listed Garden Grove California 92845
Not listed Long Beach California 90813
Not listed National City California 91950
Not listed Oakland California 94612
Not listed Pico Rivera California 90660
Not listed San Diego California 92102
Not listed San Diego California 92123
Not listed Santa Ana California 92701
Not listed Sherman Oaks California 91403
Not listed Washington D.C. District of Columbia 20016
Not listed Fort Lauderdale Florida 33301
Not listed Fort Lauderdale Florida 33308
Not listed Fort Lauderdale Florida 33334
Not listed Kissimmee Florida 34741
Not listed North Miami Florida 33162
Not listed Orlando Florida 32810
Not listed Atlanta Georgia 30308
Not listed Hoffman Estates Illinois 60169
Not listed Lake Charles Louisiana 70629
Not listed Flowood Mississippi 39232
Not listed St Louis Missouri 63118
Not listed St Louis Missouri 63128
Not listed Marlton New Jersey 08053
Not listed Holliswood New York 11423
Not listed Dayton Ohio 45417
Not listed Philadelphia Pennsylvania 19139
Not listed Austin Texas 78731
Not listed Austin Texas 78754
Not listed Dallas Texas 75231
Not listed Dallas Texas 75243
Not listed Houston Texas 77007

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 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01683058, 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 Mar 30, 2015 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01683058 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →