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Safety and Efficacy of Cariprazine for Mania

NCT01058096 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2017-04-17

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.

DRUG

Placebo

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

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
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • India

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 NCT01058096 on ClinicalTrials.gov