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

Withdrawn before enrolling · Phase 4

Conditions studied: Bipolar Disorder

In brief

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

Key facts

Study ID

NCT01075126

Run by

Lawson, William B., M.D., PhD, DFAPA

People needed

50

Starts

2006-12-01

Expected to finish

2006-12-01

Last updated by the study team

2010-02-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Howard University Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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