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Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

NCT00852202 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2018-08-23

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.

Conditions

Interventions

DRUG

cariprazine

Drug: cariprazine (0.25 - 0.75 mg/day)

DRUG

cariprazine

Drug: cariprazine (1.5 - 3.0 mg/day)

DRUG

placebo

placebo capsules, oral administration, once daily dosing

Sponsors & Collaborators

  • Gedeon Richter Ltd.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • William Greenberg, MD · Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-06-15
Completion
2010-06-15

Countries

  • United States

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 NCT00852202 on ClinicalTrials.gov