Overview

This trial is active, not recruiting.

Condition bipolar disorder
Treatment depakote-er
Phase phase 4
Sponsor Cambridge Health Alliance
Collaborator Northwestern University
Start date August 2003
End date September 2005
Trial size 25 participants
Trial identifier NCT00226343, 2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Anxiety and Depressive Symptom severity
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Phase 4 Study: Double-Blind Placebo-Controlled Trial of Depakote-ER for Depressive and Anxiety Symptoms in Non-Refractory Bipolar Depression
Principal investigator Robert T Dunn, MD, PhD
Description Study is 6 weeks long, with 7 clinical visits.
Trial information was received from ClinicalTrials.gov and was last updated in April 2006.
Information provided to ClinicalTrials.gov by Cambridge Health Alliance.