Study Stopped
key investigator relocated.
Safety Study of Depakote Versus Lithium in African Americans With Bipolar Disorder
Depakote Vs. Lithium in African Americans With Bipolar Disorder
1 other identifier
interventional
50
1 country
1
Brief Summary
It is hypothesized that Depakote will be better tolerated then lithium in treating African Americans with bipolar disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 23, 2010
CompletedFirst Posted
Study publicly available on registry
February 24, 2010
CompletedFebruary 24, 2010
February 1, 2010
Same day
February 23, 2010
February 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
psychopathology: YMRS, MADRS
Tolerability: Uku side effect rating, drop out rate, failure to switch rate
Secondary Outcomes (1)
HAMD, CGI-BP, HAM A,CORE, MADRS
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lawson, William B., M.D., PhD, DFAPAlead
- Abbottcollaborator
Study Sites (1)
Howard University Hospital
Washington D.C., District of Columbia, 20060, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William B. Lawson, MD, PhD
Professor and Chair, Howard University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
Study Record Dates
First Submitted
February 23, 2010
First Posted
February 24, 2010
Study Start
December 1, 2006
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
February 24, 2010
Record last verified: 2010-02