Status:
COMPLETED
Depakote-ER for Depressive and Bipolar Depression
Lead Sponsor:
Cambridge Health Alliance
Collaborating Sponsors:
Northwestern University
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Obtain information using a randomized treatment to assess the antidepressant and anxiolytic efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive episodes.
Detailed Description
Study is 6 weeks long, with 7 clinical visits.
Eligibility Criteria
Inclusion
- DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS \< 12; MADRS \> 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics
Exclusion
- Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00226343
Start Date
August 1 2003
End Date
August 1 2006
Last Update
April 18 2017
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