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

NCT01683058 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2015-03-31

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Aripiprazole IM Depot

Aripiprazole IM Depot 400 mg or 300 mg

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Otsuka America Pharmaceutical

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States
  • Croatia
  • Latvia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01683058 on ClinicalTrials.gov