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Completed

NCT Number: NCT00852202

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

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

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Key information

Conditions

Bipolar Depression Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Forest Investigative Site 005, Encino, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cariprazine

Drug

Drug: cariprazine (0.25 - 0.75 mg/day)

Placebo

Drug

placebo capsules, oral administration, once daily dosing

Primary outcomes

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

    Time frame: Baseline to Week 8

    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.

Secondary outcomes

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

    Time frame: Baseline to Week 8

    The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Collaborators

  • Gedeon Richter Ltd.

Registry information

Official study title

A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 26, 2009
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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