Depakote-ER for Depressive and Bipolar Depression

Last updated: April 17, 2017
Sponsor: Cambridge Health Alliance
Overall Status: Completed

Phase

4

Condition

Bipolar Disorder

Mood Disorders

Depression

Treatment

N/A

Clinical Study ID

NCT00226343
CHA-IRB-0007/07/03
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 adequatecontraception; MRS < 12; MADRS > 17; no other baseline mood stabilizing drugs,antidepressants or antipsychotics

Exclusion

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

Total Participants: 25
Study Start date:
August 01, 2003
Estimated Completion Date:
August 31, 2006

Study Description

Study is 6 weeks long, with 7 clinical visits.

Connect with a study center

  • Cambridge Health Alliance

    Cambridge, Massachusetts 02139
    United States

    Site Not Available

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