NCT00852202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

June 30, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2010

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

August 23, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

February 25, 2009

Results QC Date

June 25, 2018

Last Update Submit

August 22, 2018

Conditions

Bipolar Depression

Keywords

bipolardepression

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)

    The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity.

    Baseline to Week 8

Secondary Outcomes (1)

  • Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I )

    Baseline to Week 8

Study Arms (3)

1

EXPERIMENTAL

0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing.

Drug: cariprazine

2

EXPERIMENTAL

1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.

Drug: cariprazine

3

PLACEBO COMPARATOR

Matching placebo capsules, oral administration, once daily dosing.

Drug: placebo

Interventions

cariprazineDRUG

Drug: cariprazine (0.25 - 0.75 mg/day)

1
placeboDRUG

placebo capsules, oral administration, once daily dosing

3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Forest Investigative Site 005

Encino, California, 91316, United States

Location

Forest Investigative Site 017

Garden Grove, California, 92845, United States

Location

Forest Investigative Site 027

National City, California, 91950, United States

Location

Forest Investigative Site 013

Newport Beach, California, 92660, United States

Location

Forest Investigative Site 010

Oceanside, California, 92056, United States

Location

Forest Investigative Site 020

Bradenton, Florida, 34208, United States

Location

Forest Investigative Site 007

Jacksonville, Florida, 32216, United States

Location

Forest Investigative Site 019

Kissimmee, Florida, 34741, United States

Location

Forest Investigative Site 026

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 012

West Palm Beach, Florida, 33407, United States

Location

Forest Investigative Site 024

Glen Burnie, Maryland, 21061, United States

Location

Forest Investigative Site 029

Creve Coeur, Missouri, 63141, United States

Location

Forest Investigative Site 002

Omaha, Nebraska, 68131, United States

Location

Forest Investigative Site 028

Cherry Hill, New Jersey, 08002, United States

Location

Forest Investigative Site 001

The Bronx, New York, 10467, United States

Location

Forest Investigative Site 018

Durham, North Carolina, 27710, United States

Location

Forest Investigative Site 004

Dayton, Ohio, 45417, United States

Location

Forest Investigative Site 022

Mason, Ohio, 45040, United States

Location

Forest Investigative Site 015

Portland, Oregon, 97210, United States

Location

Forest Investigative Site 006

Media, Pennsylvania, 19063, United States

Location

Forest Investigative Site 011

Philadelphia, Pennsylvania, 19107, United States

Location

Forest Investigative Site 014

Nashville, Tennessee, 37212, United States

Location

Forest Investigative Site 023

Irving, Texas, 75062, United States

Location

Forest Investigative Site 003

Woodstock, Vermont, 05091, United States

Location

Forest Investigative Site 009

Bellevue, Washington, 98004, United States

Location

Forest Investigative Site 016

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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.

    PMID: 31969269DERIVED

MeSH Terms

Conditions

Bipolar DisorderDepression

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan Sales LLC
IR-CTRegistration@allergan.com
877-277-8566

Study Officials

  • William Greenberg, MD

    Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

June 30, 2009

Primary Completion

June 15, 2010

Study Completion

June 15, 2010

Last Updated

August 23, 2018

Results First Posted

August 23, 2018

Record last verified: 2018-08

Locations

US(26)