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

This study has been withdrawn prior to enrollment.
(key investigator relocated.)
Sponsor:
Collaborator:
Abbott
Information provided by:
Lawson, William B., M.D., PhD, DFAPA
ClinicalTrials.gov Identifier:
NCT01075126
First received: February 23, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Bipolar Disorder
 Drug: Depakote
Drug: Lithium
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Depakote Vs. Lithium in African Americans With Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Further study details as provided by Lawson, William B., M.D., PhD, DFAPA:

Primary Outcome Measures:
  • psychopathology: YMRS, MADRS
  • Tolerability: Uku side effect rating, drop out rate, failure to switch rate

Secondary Outcome Measures:
  • HAMD, CGI-BP, HAM A,CORE, MADRS

Estimated Enrollment: 50
Study Start Date: December 2006
Estimated Study Completion Date: December 2006
Estimated Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075126

Locations
United States, District of Columbia
Howard University Hospital
Washington, District of Columbia, United States, 20060
Sponsors and Collaborators
Lawson, William B., M.D., PhD, DFAPA
Abbott
Investigators
Principal Investigator: William B. Lawson, MD, PhD Professor and Chair, Howard University College of Medicine
  More Information

No publications provided

Responsible Party: Lawson, William B., M.D., PhD, DFAPA., Howard University
ClinicalTrials.gov Identifier: NCT01075126     History of Changes
Other Study ID Numbers: Abbottdepakote1
Study First Received: February 23, 2010
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Lawson, William B., M.D., PhD, DFAPA:
bipolar affective disorder
African American
antimanic
lithium
depakote

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Lithium Carbonate
Lithium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipsychotic Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on June 13, 2013