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

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

Detailed Description
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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.

Official Title
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Depakote Vs. Lithium in African Americans With Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Depakote
* Drug: Lithium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Depakote|nan|
|Drug: Lithium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychopathology: YMRS, MADRS |  |  | 
| Tolerability: Uku side effect rating, drop out rate, failure to switch rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD, CGI-BP, HAM A,CORE, MADRS |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar affective disorder, African American, antimanic, lithium, depakote