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

Condition(s) targeted: Bipolar Disorder

Intervention: Depakote (Drug); Lithium (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Lawson, William B., M.D., PhD, DFAPA

Official(s) and/or principal investigator(s):
William B. Lawson, MD, PhD, Principal Investigator, Affiliation: Professor and Chair, Howard University College of Medicine

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

Official title: Depakote Vs. Lithium in African Americans With Bipolar Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

psychopathology: YMRS, MADRS

Tolerability: Uku side effect rating, drop out rate, failure to switch rate

Secondary outcome: HAMD, CGI-BP, HAM A,CORE, MADRS

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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Howard University Hospital, Washington, District of Columbia 20060, United States

Starting date: December 2006
Last updated: February 23, 2010