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Trial record 1 of 1 for:    NCT01396447
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Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

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ClinicalTrials.gov Identifier: NCT01396447
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression, Bipolar Drug: Placebo Drug: Cariprazine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression
Actual Study Start Date : July 26, 2011
Actual Primary Completion Date : January 10, 2014
Actual Study Completion Date : January 10, 2014

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received placebo orally once a day for 8 weeks.
 Drug: Placebo
Placebo was supplied in capsules.
Experimental: Cariprazine 0.75 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
 Drug: Cariprazine
Cariprazine was supplied in capsules.
Experimental: Cariprazine 1.5 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
 Drug: Cariprazine
Cariprazine was supplied in capsules.
Experimental: Cariprazine 3.0 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
 Drug: Cariprazine
Cariprazine was supplied in capsules.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396447


Locations
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Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
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Study Director: Willie Earley, MD Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01396447    
Other Study ID Numbers: RGH-MD-56
2011-002334-39 ( EudraCT Number )
First Posted: July 18, 2011    Key Record Dates
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018
Last Verified: March 2018
Keywords provided by Forest Laboratories:
Bipolar I disorder
Bipolar depression
Depression
Bipolar disorder
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
 Cariprazine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs