Overview

Depakote-ER for Depressive and Bipolar Depression

Status:
Completed

Trial end date:
2006-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Cambridge Health Alliance

Collaborator:

Northwestern University

Treatments:

Valproic Acid

Criteria

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