Safety and Efficacy of Cariprazine for Mania

Part of paid clinical trials in Long Beach, California.

Sponsor
Forest Laboratories
Study ID
NCT01058096
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Cariprazine — DRUG
    Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.
  • Placebo — DRUG
    Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.

Study Details

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.

Key Dates

Start date
Feb 28, 2010
Status verified
Mar 2017
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

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

Arms

  • Experimental: Cariprazine
    Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
  • Placebo Comparator: Placebo
    Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.

Primary Outcome Measure

Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 [ Time Frame: Baseline, Week 3 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Forest Investigative Site 004Long BeachCalifornia90813-
Forest Investigative Site 005RiversideCalifornia92506-
Forest Investigative Site 007San DiegoCalifornia92123-
Forest Investigative Site 009ChicagoIllinois60640-
Forest Investigative Site 006Lake CharlesLouisiana70601-
Forest Investigative Site 001FlowoodMississippi39232-
Forest Investigative Site 003Creve CouerMissouri63141-
Forest Investigative Site 008ClevelandOhio44109-
Forest Investigative Site 010Oklahoma CityOklahoma73116-
Forest Investigative Site 002HoustonTexas77008-

Find similar trials in Long Beach, CA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Forest Investigative· Long Beach, CAForest Investigative· Riverside, CAForest Investigative· San Diego, CAForest Investigative· Chicago, ILForest Investigative· Lake Charles, LAForest Investigative· Flowood, MS

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