Depakote ER in Bipolar Depression
Completed · Phase 4
Conditions studied: Depression, Bipolar
In brief
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 brain imaging techniques.
Key facts
- Study ID
- NCT00186186
- Run by
- Stanford University
- People needed
- 28
- Starts
- 2004-01-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2017-04-12
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University Bipolar Disorders Clinic — Stanford, California, United States
Full record on ClinicalTrials.gov
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