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Safety and Efficacy of Cariprazine for Bipolar I Disorder

NCT01058668 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 497

Last updated 2017-04-12

Study results available
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Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Conditions

Interventions

DRUG

Cariprazine

Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

DRUG

Placebo

Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.

Sponsors & Collaborators

  • Gedeon Richter Ltd.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Elizabeth Diaz, MD · Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Croatia
  • Romania
  • Russia
  • Serbia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT01058668 on ClinicalTrials.gov