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

Sponsor

Lawson, William B., M.D., PhD, DFAPA (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01075126

Collaborator

Abbott (Industry)

Enrollment

Location

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: Depakote Drug: Lithium	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Depakote Vs. Lithium in African Americans With Bipolar Disorder

Study Start Date :

Dec 1, 2006

Anticipated Primary Completion Date :

Dec 1, 2006

Anticipated Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

psychopathology: YMRS, MADRS []
Tolerability: Uku side effect rating, drop out rate, failure to switch rate []

Secondary Outcome Measures

HAMD, CGI-BP, HAM A,CORE, MADRS []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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