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

Bipolar Disorder Clinical Trial

Official title:

Depakote Vs. Lithium in African Americans With Bipolar Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01075126
• Other study ID #: Abbottdepakote1
• Status: Withdrawn
• Phase: Phase 4
• First received: February 23, 2010
• Last updated: February 23, 2010
• Start date: December 2006
• Est. completion date: December 2006

Study information

• Verified date: February 2010
• Source: Lawson, William B., M.D., PhD, DFAPA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 50
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Depakote

• Lithium

Locations

Country	Name	City	State
United States	Howard University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Lawson, William B., M.D., PhD, DFAPA	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychopathology: YMRS, MADRS
Primary	Tolerability: Uku side effect rating, drop out rate, failure to switch rate
Secondary	HAMD, CGI-BP, HAM A,CORE, MADRS