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An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia

NCT01129882 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 709

Last updated 2020-01-06

Study results available
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Summary

The primary objective of this study was to continue to provide aripiprazole intramuscular (IM) depot treatment (400 milligrams \[mg\] or 300 mg) to participants with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248. In addition, the secondary objective was to collect additional long-term safety data on aripiprazole IM depot treatment.

Conditions

Interventions

DRUG

Aripiprazole

Aripiprazole IM depot - 300 mg or 400 mg

Sponsors & Collaborators

  • 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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-24
Primary Completion
2018-12-06
Completion
2018-12-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Chile
  • Croatia
  • Estonia
  • Finland
  • Hungary
  • India
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand

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 NCT01129882 on ClinicalTrials.gov