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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00257972 |
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Date of registration:
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23/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Aripiprazole in Patients With Bipolar I Disorder
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Scientific title:
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Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00257972 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Bulgaria
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Czech Republic
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Estonia
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France
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Germany
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Hungary
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Italy
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Netherlands
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Norway
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Poland
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Portugal
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Russian Federation
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South Africa
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Spain
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Sweden
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of bipolar I disorder, manic or mixed episode
Exclusion Criteria:
- First manic or mixed episode
- Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
- Participation in a previous clinical trial within the past month or ever participated
in a trial with aripiprazole
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bipolar Disorder
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Intervention(s)
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Drug: aripiprazole
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Primary Outcome(s)
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Change from baseline to endpoint in a mania rating scale
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Secondary Outcome(s)
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Response rate and Clinical Global Impression Scale at endpoint
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Secondary ID(s)
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CN138-134
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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