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

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

Status and phase

Withdrawn

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: Lithium

Drug: Depakote

Study type

Interventional

Funder types

Industry

Identifiers

NCT01075126

Abbottdepakote1

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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