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

Information source: Lawson, William B., M.D., PhD, DFAPA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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Status: Withdrawn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

Summary

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

Clinical Details

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.

Eligibility

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

Locations and Contacts

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

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

Page last updated: August 23, 2015

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