Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Forest Laboratories
Study ID
NCT00488618
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Cariprazine (RGH-188) — DRUG
    Cariprazine 3 mg - 12 mg oral administration, once per day.
  • Placebo — DRUG
    Dose-matched placebo oral administration, once per day.

Study Details

This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo

Key Dates

Start date
Jun 30, 2007
Status verified
Mar 2017
Primary completion
Jul 31, 2008
Completion
Jul 31, 2008

Study Design

Enrollment
238 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 (1)

FacilityCityStateZIPSite coordinators
For information regarding investigative sites, contact Forest Professional AffairsSt LouisMissouri63045-

Find similar trials in St Louis, MO

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
For information regarding investigative sites, contact Forest Professional Affairs· St Louis, MO

Related Studies