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NCT00226343 Clinical Trial

Depakote-ER for Depressive and Bipolar Depression

Bipolar Disorder Clinical Trial

Official title:
Phase 4 Study: Double-blind Placebo-controlled Trial of Depakote-ER for Depressive and Anxiety Symptoms in Non-refractory Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00226343
Other study ID # CHA-IRB-0007/07/03
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated April 17, 2017
Start date August 2003
Est. completion date August 2006

Study information
Verified date April 2017
Source Cambridge Health Alliance
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Study is 6 weeks long, with 7 clinical visits.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date August 2006
Est. primary completion date January 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Depakote-ER

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Cambridge Health Alliance Northwestern University

Outcome
Type Measure Description Time frame Safety issue
Primary Anxiety and Depressive Symptom severity
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