Safety Study of Depakote Versus Lithium in African Americans With Bipolar Disorder

Phase 4

Withdrawn

• Conditions: Bipolar Disorder

• Registration Number: NCT01075126
• Lead Sponsor: Lawson, William B., M.D., PhD, DFAPA

Brief Summary

It is hypothesized that Depakote will be better tolerated then lithium in treating African Americans with bipolar disorder.

Detailed Description

This is a 14 week randomized open study of 50 inpatients or outpatients with bipolar I r II. African American subjects will receive lithium or depakote ER. Measures will be made of psychopathology, reported side effects, and study completers. Measures will also be made of RBC/plasma lithium to determine if this level is better predictive of lithium tolerability.

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2010-02
• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-23
• Last Update Submitted: 2010-02-23
• Study First Posted: 2010-02-24
• Last Update Posted: 2010-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Male or female
• Females must be using a contraceptive
• Understand and sing informed consent
• Meet criteria for DSM IV bipolar I or II
• Must have been receiving treatment with depakote or lithium for at least 4 weeks
• Must not have used illicit substances 48 hours before the study

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Exclusion Criteria

• Not takin g lithium o valproate at time of screening
• Alcohol intoxicated or using drugs of abuse other then cannibis
• Presence of psychotic features
• Participation in clinical trail within 1 month of study
• Female subjects pregnant or nursing
• Serious unstable medical or psychiatric illness
• Uncorrected hypothyroidism or hyperthyroidism
• Seizures without a clear and resolved etiology
• Hypersensitivity or intolerance to lithium or valproic acid
• Treatment with injectable depot neuroleptic less then one dosing interval
• Treatment with reversible MAOI, guanethidine, or guanadrel within i week of study
• Treatment with fluoxetine within 8 weekS of study
• treatment with clozapine or ECT 3 months prior to study
• current diagnosis of schizophrenia or other psychotic disorder
• judged to be at serious suicidal risk

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
psychopathology: YMRS, MADRS
Tolerability: Uku side effect rating, drop out rate, failure to switch rate

Secondary Outcome Measures

Name	Time	Method
HAMD, CGI-BP, HAM A,CORE, MADRS

Trial Locations

Locations (1)

Howard University Hospital; 🇺🇸 Washington, District of Columbia, United States