Status:
COMPLETED
Depakote ER in Bipolar Depression
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Abbott
National Alliance for Research on Schizophrenia and Depression
Conditions:
Depression, Bipolar
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar depression and to evaluate metabolic and GABA changes with Depakote ER administration using PET and MRI/MRS br...
Detailed Description
Mood disorders are important public health problems. Bipolar disorder is a major psychiatric disorder characterized by mood cycles alternating between mania and depression and affects approximately 1%...
Eligibility Criteria
Inclusion
- Bipolar I, II or NOS currently suffering from depression
- Both: both female and male participants are being studied
- Adults 18 years and older of any race
Exclusion
- Schizophrenia or schizoaffective disorder and other disorders excluded at the discretion of the investigator's discretion
- Substance dependence within the past 3 months and abuse within the past 2 weeks prior to study.
- Positive screen for psychoactive drugs, stimulants or drugs of abuse (excluding marijuana, as long as dependence and abuse are ruled out according to DSM-IV)
- Significant risk harm to self or others based on history and mental status exam
- Clinically significant or unstable medical condition
- Unstable thyroid pathology and treatment initiated or altered within the past 3 months
- Clinically significant abnormal laboratory test results, vital signs, as judged by the investigators
- Women pregnant or nursing, or WOCBP who do not use adequate contraception or who are judged to be unreliable in their use of contraception
- Subjects who failed (because of inefficacy or adverse effects) an adequate trial of Depakote; eligible patient's may not have received Depakote within 30 days of screen
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00186186
Start Date
January 1 2004
End Date
January 1 2009
Last Update
April 12 2017
Active Locations (1)
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1
Stanford University Bipolar Disorders Clinic
Stanford, California, United States, 94305-5723