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

Depakote Vs. Lithium in African Americans With Bipolar Disorder

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01075126

Enrollment

Registered

2010-02-24

Start date

2006-12-31

Completion date

2006-12-31

Last updated

2010-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

bipolar affective disorder, African American, antimanic, lithium, depakote

Brief summary

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

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.

Interventions

DRUGDepakote

DRUGLithium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
psychopathology: YMRS, MADRS	—
Tolerability: Uku side effect rating, drop out rate, failure to switch rate	—

Secondary

Measure	Time frame
HAMD, CGI-BP, HAM A,CORE, MADRS	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026