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

Part of paid clinical trials in Encino, California.

Sponsor
Forest Laboratories
Study ID
NCT00852202
Phase
PHASE2
Status
Completed

Conditions

  • Bipolar Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • cariprazine — DRUG
    Drug: cariprazine (0.25 - 0.75 mg/day)
  • cariprazine — DRUG
    Drug: cariprazine (1.5 - 3.0 mg/day)
  • placebo — DRUG
    placebo capsules, oral administration, once daily dosing

Study Details

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

Key Dates

Start date
Jun 30, 2009
Status verified
Aug 2018
Primary completion
Jun 15, 2010
Completion
Jun 15, 2010

Study Design

Enrollment
234 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing.
  • Experimental: 2
    1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.
  • Placebo Comparator: 3
    Matching placebo capsules, oral administration, once daily dosing.

Primary Outcome Measure

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline to Week 8 ]

Locations (26)

FacilityCityStateZIPSite coordinators
Forest Investigative Site 005EncinoCalifornia91316-
Forest Investigative Site 017Garden GroveCalifornia92845-
Forest Investigative Site 027National CityCalifornia91950-
Forest Investigative Site 013Newport BeachCalifornia92660-
Forest Investigative Site 010OceansideCalifornia92056-
Forest Investigative Site 020BradentonFlorida34208-
Forest Investigative Site 007JacksonvilleFlorida32216-
Forest Investigative Site 019KissimmeeFlorida34741-
Forest Investigative Site 026OrlandoFlorida32806-
Forest Investigative Site 012West Palm BeachFlorida33407-
Forest Investigative Site 024Glen BurnieMaryland21061-
Forest Investigative Site 029Creve CoeurMissouri63141-
Forest Investigative Site 002OmahaNebraska68131-
Forest Investigative Site 028Cherry HillNew Jersey08002-
Forest Investigative Site 001The BronxNew York10467-
Forest Investigative Site 018DurhamNorth Carolina27710-
Forest Investigative Site 004DaytonOhio45417-
Forest Investigative Site 022MasonOhio45040-
Forest Investigative Site 015PortlandOregon97210-
Forest Investigative Site 006MediaPennsylvania19063-
Forest Investigative Site 011PhiladelphiaPennsylvania19107-
Forest Investigative Site 014NashvilleTennessee37212-
Forest Investigative Site 023IrvingTexas75062-
Forest Investigative Site 003WoodstockVermont05091-
Forest Investigative Site 009BellevueWashington98004-
Forest Investigative Site 016SeattleWashington98104-

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