Safety Study of Depakote Versus Lithium in African Americ... | NCT01075126

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

NCT01075126

Sponsor

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

Status

Withdrawn

Last Update Posted

Feb 24, 2010Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Bipolar Disorder

Interventions

Depakote
Lithium

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

key investigator relocated.

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2006Estimated

Completion Date

Dec 2006Estimated

First Submitted Date

Feb 23, 2010

First Submission Date that Met QC Criteria

Feb 23, 2010

First Posted Date

Feb 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2010

Last Update Posted Date

Feb 24, 2010Estimated

Name	Class
Abbott	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Measure	Description	Time Frame
HAMD, CGI-BP, HAM A,CORE, MADRS

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William B. Lawson, MD, PhD	Professor and Chair, Howard University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Howard University Hospital		Washington D.C.	District of Columbia	20060	United States

ID	Term
D001714	Bipolar Disorder

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D014635	Valproic Acid
D008094	Lithium

Ancestor Terms

ID	Term
D010421	Pentanoic Acids
D014631	Valerates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided

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

Name	Type	Description	Arm Group Labels	Other Names
Depakote	Drug
Lithium	Drug