MedTrace Logo

Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

NCT01396447 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 584

Last updated 2018-05-01

Study results available
· View outcomes & findings →

Summary

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

Conditions

  • Depression, Bipolar

Interventions

DRUG

Placebo

Placebo was supplied in capsules.

DRUG

Cariprazine

Cariprazine was supplied in capsules.

Sponsors & Collaborators

  • Gedeon Richter Ltd.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Willie Earley, MD · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-26
Primary Completion
2014-01-10
Completion
2014-01-10

Countries

  • United States
  • Bulgaria
  • Canada
  • Colombia
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT01396447 on ClinicalTrials.gov