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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Compliance, Tolerability, Efficacy and Adverse Events in Bipolar Tients From Valproic Acid to Depakote ER

NCT00211250

Mood Disorder

COMPLETED PHASE4

Bipolar Disorder Research Study for Ages 12 and Older

NCT00211263

Bipolar Disorder

COMPLETED NA

Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness

NCT00071253

Bipolar Disorder

TERMINATED PHASE4

An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder

NCT00060905

Bipolar Disorder

COMPLETED PHASE3

Prevention of Relapse & Recurrence of Bipolar Depression

NCT00961961

Bipolar Disorder

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Depakote

Intervention Type DRUG

Lithium

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No