A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder
| City: |
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Tampa |
| State: |
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Florida |
| Zip Code: |
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33613 |
| Conditions: |
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Mania - Bipolar I Disorder |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01058668 |
| Primary Contact: |
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Study Director
Elizabeth Diaz, MD
Forest Laboratories
Sandra Beaird, PhD
Phone: 1-800-678-1605 ext. 66297
Email: info@forestpharm.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Tampa, Florida 33613
United States
There is no listed contact information for this specific location.
Site Status: Withdrawn |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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