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

• Status: Withdrawn
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson, William B., M.D., PhD, DFAPA
• Collaborator: Abbott
• Treatments: Lithium Carbonate; Valproic Acid

Criteria

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