Depakote-ER for Depressive and Bipolar Depression

Phase 4

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00226343
• Lead Sponsor: Cambridge Health Alliance

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.

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-27
• Primary Completion: 2006-01
• Study Completion: 2006-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety and Depressive Symptom severity