Clinical trial NCT00852202: Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
Official title: A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar Depression
Keywords: bipolar
depression
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2009-02-26
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Men and women, 18-65 years old
* Currently meet the DSM-IV-TR criteria for Bipolar I or II Disorder without psychotic features, with a current depressive episode
* A verified previous manic, hypomanic, or mixed episode
* Score of 20 or higher on the HAMD-17
* Score of 2 or higher on Item 1 of the HAMD

Exclusion Criteria:

* Score greater than 12 on the Young Mania Rating Scale
* Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months prior to Visit 1
* Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or specific phobias is acceptable)

Primary outcomes:
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I )
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Encino
country: United States
facility: Forest Investigative Site 005
state: California
city: Garden Grove
country: United States
facility: Forest Investigative Site 017
state: California
city: National City
country: United States
facility: Forest Investigative Site 027
state: California
city: Newport Beach
country: United States
facility: Forest Investigative Site 013
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site 010
state: California
city: Bradenton
country: United States
facility: Forest Investigative Site 020
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 007
state: Florida
city: Kissimmee
country: United States
facility: Forest Investigative Site 019
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 026
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 012
state: Florida
city: Glen Burnie
country: United States
facility: Forest Investigative Site 024
state: Maryland
city: Creve Coeur
country: United States
facility: Forest Investigative Site 029
state: Missouri
city: Omaha
country: United States
facility: Forest Investigative Site 002
state: Nebraska
city: Cherry Hill
country: United States
facility: Forest Investigative Site 028
state: New Jersey
city: Bronx
country: United States
facility: Forest Investigative Site 001
state: New York
city: Durham
country: United States
facility: Forest Investigative Site 018
state: North Carolina
city: Dayton
country: United States
facility: Forest Investigative Site 004
state: Ohio
city: Mason
country: United States
facility: Forest Investigative Site 022
state: Ohio
city: Portland
country: United States
facility: Forest Investigative Site 015
state: Oregon
city: Media
country: United States
facility: Forest Investigative Site 006
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 011
state: Pennsylvania
city: Nashville
country: United States
facility: Forest Investigative Site 014
state: Tennessee
city: Irving
country: United States
facility: Forest Investigative Site 023
state: Texas
city: Woodstock
country: United States
facility: Forest Investigative Site 003
state: Vermont
city: Bellevue
country: United States
facility: Forest Investigative Site 009
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site 016
state: Washington
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
name: William Greenberg, MD
role: STUDY_DIRECTOR
References:
citation: Earley WR, Burgess M, Rekeda L, Hankinson A, McIntyre RS, Suppes T, Calabrese JR, Yatham LN. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J Affect Disord. 2020 Feb 15;263:386-395. doi: 10.1016/j.jad.2019.11.098. Epub 2019 Nov 22.