Depakote ER in Bipolar Depression

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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 brain imaging techniques.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborators: Abbott; National Alliance for Research on Schizophrenia and Depression
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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