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

Primary Purpose

Bipolar Disorder

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Depakote
Lithium
Sponsored by
Lawson, William B., M.D., PhD, DFAPA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar affective disorder, African American, antimanic, lithium, depakote

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Howard University Hospital

Outcomes

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

Full Information

First Posted
February 23, 2010
Last Updated
February 23, 2010
Sponsor
Lawson, William B., M.D., PhD, DFAPA
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT01075126
Brief Title
Safety Study of Depakote Versus Lithium in African Americans With Bipolar Disorder
Official Title
Depakote Vs. Lithium in African Americans With Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Withdrawn
Why Stopped
key investigator relocated.
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2006 (Anticipated)
Study Completion Date
December 2006 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Lawson, William B., M.D., PhD, DFAPA
Collaborators
Abbott

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
bipolar affective disorder, African American, antimanic, lithium, depakote

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Depakote
Intervention Type
Drug
Intervention Name(s)
Lithium
Primary Outcome Measure Information:
Title
psychopathology: YMRS, MADRS
Title
Tolerability: Uku side effect rating, drop out rate, failure to switch rate
Secondary Outcome Measure Information:
Title
HAMD, CGI-BP, HAM A,CORE, MADRS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William B. Lawson, MD, PhD
Organizational Affiliation
Professor and Chair, Howard University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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