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Completed

NCT Number: NCT01396447

Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

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Key information

Conditions

Depression, Bipolar 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 311, Kardzhali, Bulgaria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants who have provided informed consent prior to any study specific procedures.
  • Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
  • Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
  • Verified previous manic or mixed episode.
  • Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
  • Participants with a HAMD-17 item 1 score ≥ 2.
  • Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion criteria

  • Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
  • Women who are pregnant or breast feeding
  • Participants with Young Mania Rating Scale (YMRS) total score > 10
  • Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.

Treatment and study plan

Placebo

Drug

Placebo was supplied in capsules.

Cariprazine

Drug

Cariprazine was supplied in capsules.

Primary outcomes

  1. Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6

    Time frame: Baseline to Week 6

    The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.

Secondary outcomes

  1. Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6

    Time frame: Baseline to Week 6

    The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Collaborators

  • Gedeon Richter Ltd.

Registry information

Official study title

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 18, 2011
Registry last updated
May 1, 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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