Safety and Efficacy of Cariprazine for Bipolar I Disorder
This study is currently recruiting participants.
Verified by Forest Laboratories, September 2010
Sponsor: Forest Laboratories
Collaborator: Gedeon Richter Ltd.
Information provided by: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01058668
Purpose
The objective of this study is to evaluate the efficacy, safety,
and tolerability of cariprazine monotherapy versus placebo for the
treatment of acute manic or mixed episodes associated with bipolar
I disorder.
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Mania
Bipolar I Disorder
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Drug: Cariprazine low dose
Drug: Cariprazine high dose
Drug: Placebo
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Phase III
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Study
Type:
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Interventional
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Study
Design:
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Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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Official
Title:
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A Double-Blind,
Placebo-Controlled, Evaluation of the Safety and Efficacy of
Cariprazine in Patients With Acute Mania Associated With Bipolar I
Disorder
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Eligibility
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Ages Eligible for
Study:
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18 Years to 65
Years
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Genders Eligible for
Study:
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Both
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Accepts Healthy
Volunteers:
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No
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Criteria
Inclusion Criteria:
- Patients who have provided
informed consent prior to any study specific procedures
- Patients 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 for Diagnostic
and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
manic or mixed type with or without psychotic symptoms
- Voluntarily hospitalized for
current manic episode
- Patients with normal physical
examination, laboratory, vital signs,and/ or electrocardiogram
(ECG)
Exclusion Criteria:
- Patients 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 six
months
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
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Study
Director:
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Joyce Tsai, Phd -
Forest Laboratories
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ClinicalTrials.gov
Identifier:
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Other Study ID
Numbers:
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RGH-MD-33
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Study First
Received:
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January 27, 2010
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Last
Updated:
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September 9, 2010
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Health
Authority:
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United
States: Food and Drug
Administration; Lithuania: State Medicine Control Agency -
Ministry of Health; Croatia: Agency for Medicinal Product
and Medical Devices; Ukraine: State Pharmacological Center -
Ministry of Health; Russia: Ministry of Health and Social
Development of the Russian Federation; Serbia and
Montenegro: Agency for Drugs and Medicinal Devices; Romania:
National Medicines Agency
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Keywords provided by Forest Laboratories:
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Acute Mania
Bipolar I Disorder
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Additional relevant MeSH terms:
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Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
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ClinicalTrials.gov processed this record on September 26,
2010
