Safety Study of Depakote Versus Lithium in African Americans With Bipolar Disorder
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ClinicalTrials.gov Identifier: NCT01075126
Recruitment Status :
(key investigator relocated.)
It is hypothesized that Depakote will be better tolerated then lithium in treating African Americans with bipolar disorder.
Condition or disease
Drug: DepakoteDrug: Lithium
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.
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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