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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01075126
Recruitment Status : Withdrawn (key investigator relocated.)
First Posted : February 24, 2010
Last Update Posted : February 24, 2010
Sponsor:
Collaborator:
Abbott
Information provided by:
Lawson, William B., M.D., PhD, DFAPA

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Depakote Drug: Lithium Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Depakote Vs. Lithium in African Americans With Bipolar Disorder
Study Start Date : December 2006
Estimated Primary Completion Date : December 2006
Estimated Study Completion Date : December 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. psychopathology: YMRS, MADRS
  2. Tolerability: Uku side effect rating, drop out rate, failure to switch rate

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075126


Locations
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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
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Principal Investigator: William B. Lawson, MD, PhD Professor and Chair, Howard University College of Medicine
More Information
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Responsible Party: Lawson, William B., M.D., PhD, DFAPA., Howard University
ClinicalTrials.gov Identifier: NCT01075126    
Other Study ID Numbers: Abbottdepakote1
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: February 24, 2010
Last Verified: February 2010
Keywords provided by Lawson, William B., M.D., PhD, DFAPA:
bipolar affective disorder
African American
antimanic
lithium
depakote
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Psychotropic Drugs
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
GABA Agents
Neurotransmitter Agents