Depakote ER in Bipolar Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 17 December 2012
• Main ID: NCT00186186
• Date of registration: 13/09/2005
• Primary sponsor: Stanford University
• Public title: Depakote ER in Bipolar Depression
• Scientific title: Depakote ER in Bipolar Depression
• Date of first enrolment: January 2004
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00186186
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Terence A. Ketter, MD
• Affiliation: Stanford University, Department of Psychiatry and Behavioral Sciences

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Depression, Bipolar

Intervention(s)

Drug: Depakote ER

Primary Outcome(s)

Montgomery Asberg Depression Rating Scale (MADRS) [Time Frame: 7 weeks]

Secondary ID(s)

79130

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott

National Alliance for Research on Schizophrenia and Depression