Depakote-ER for Depressive and Bipolar Depression

Cambridge Health Alliance

Status and phase

Completed

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: Depakote-ER

Study type

Interventional

Funder types

Other

Identifiers

NCT00226343

CHA-IRB-0007/07/03

Details and patient eligibility

About

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.

Full description

Study is 6 weeks long, with 7 clinical visits.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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