Trial | NCT01075126  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    50
It is hypothesized that Depakote will be better tolerated then lithium in treating African Americans with bipolar disorder.
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 Started
Dec 31
2006
Primary Completion
Dec 31
2006
Anticipated
Study Completion
Dec 31
2006
Anticipated
Last Update
Feb 24
2010
Estimate

Drug Depakote

Drug Lithium

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
No Results Posted