- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00141505
PK Effects of Bifeprunox & Valproate in Bipolar I
January 15, 2015 updated by: Solvay Pharmaceuticals
Placebo-controlled Study on the Pharmacokinetics,Pharmacodynamics, Safety and Tolerability of Concurrent Valproate and Bifeprunox Administration in Subjects With Bipolar I Disorder
The study is to evaluate the effect of bifeprunox on the pharmacokinetics of valproate in subjects with Bipolar I Disorder after multiple dose administration.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States
- Site 1
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females
- 18-65 years old
- meeting DSM-IV criteria for Bipolar I Disorder, either manic or mixed episodes, with or without psychotic features
Exclusion Criteria:
- subjects who are acutely manic, acutely depressed, psychotic or subjects with a current Axis I primary psychiatric diagnosis other than Bipolar I Disorder based on DSM-IV TR criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
August 30, 2005
First Submitted That Met QC Criteria
August 30, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Estimate)
January 16, 2015
Last Update Submitted That Met QC Criteria
January 15, 2015
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- S154.2.015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bipolar I Disorder
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ProgenaBiomeRecruitingBipolar Disorder | Bipolar I Disorder | Bipolar II Disorder | Bipolar Type I Disorder | Bipolar Disorder Mild | Bipolar Disorder Moderate | Bipolar Disorder SevereUnited States
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Rush University Medical CenterThe Ryan Licht Sang Bipolar FoundationCompletedBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar Disorder I | Bipolar Affective DisorderUnited States
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Otsuka Pharmaceutical Development & Commercialization...H. Lundbeck A/SCompletedBipolar I DisorderUnited States, Taiwan, Romania, Korea, Republic of, Japan, Poland, Canada
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Professor Saad ShakirMerck Sharp & Dohme LLCCompletedBipolar I DisorderUnited Kingdom
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University of Sao PauloCompleted
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University of Sao PauloUnknown
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Merck Sharp & Dohme LLCRecruitingBipolar I DisorderUnited States
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Roxane LaboratoriesCompletedBipolar I DisorderUnited States
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Eli Lilly and CompanyCompletedBipolar I DisorderUnited States
-
Roxane LaboratoriesCompletedTreatment for Bipolar I DisorderUnited States
Clinical Trials on Bifeprunox
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Solvay PharmaceuticalsWyeth is now a wholly owned subsidiary of Pfizer; H. Lundbeck A/SCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Solvay PharmaceuticalsWyeth is now a wholly owned subsidiary of Pfizer; H. Lundbeck A/SCompletedSchizophrenia | Schizoaffective Disorder | Bipolar DisorderUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerTerminated
-
Wyeth is now a wholly owned subsidiary of PfizerSolvay PharmaceuticalsCompleted
-
Solvay PharmaceuticalsWyeth is now a wholly owned subsidiary of Pfizer; H. Lundbeck A/SCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
H. Lundbeck A/SSolvay PharmaceuticalsTerminated
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
Solvay PharmaceuticalsTerminatedPsychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's TypeUnited States, Czech Republic, Estonia, Israel, Poland