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

Last updated: February 23, 2010
Sponsor: Lawson, William B., M.D., PhD, DFAPA
Overall Status: Trial Not Available

Phase

4

Condition

Bipolar Disorder

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT01075126
Abbottdepakote1
  • Ages 18-60
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 50
Study Start date:
December 01, 2006
Estimated Completion Date:
December 31, 2006

Study 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.

Connect with a study center

  • Howard University Hospital

    Washington, District of Columbia 20060
    United States

    Site Not Available

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