Divalproex vs. Lamotrigine for Bipolar Disorder

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2007 by Tuscaloosa Research & Education Advancement Corporation. Recruitment status was Active, not recruiting

First Received on March 21, 2007. No Changes Posted

Sponsor:	Tuscaloosa Research & Education Advancement Corporation
Information provided by:	Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier:	NCT00451542

Purpose

This study is a retrospective chart review of patients treated for bipolar disorder at the TVAMC in the past four years cross-referenced with the electronic pharmacy file for having received a prescription of divalproex or lamotrigine.

Condition	Phase
Bipolar Disorder	Phase III

Study Type:	Observational
Study Design:	Observational Model: Defined Population Observational Model: Natural History Time Perspective: Cross-Sectional Time Perspective: Retrospective
Official Title:	Time to Relapse During Treatment With Divalproex vs. Lamotrigine for Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by Tuscaloosa Research & Education Advancement Corporation:

Estimated Enrollment:	1000
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2008

Detailed Description:

The primary objective of the study is to assess the long-term outcome in bipolar patients treated with divalproex versus lamotrigine in a retrospective chart review of veterans as measured by time to relapse into any significant mood episode (i.e. mania or depression). The primary hypothesis is that bipolar patients will demonstrate significantly greater time to relapse in those treated with divalproex compared to those treated with lamotrigine. The secondary objective of the study is to assess the safety and relative tolerability of divalproex and lamotrigine in this population based on discontinuation due to side or adverse effect.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Bipolar I or Bipolar II disorder
Prescription of divalproex (any formulation except for Depakene/valproic acid) or lamotrigine in the electronic pharmacy profile.
Age 19 or older
Demonstrated stability for at least 4 weeks on an adequate dose of each medication (at least 50mg/d lamotrigine or 15mg/kg/day divalpoex).
Treatment at the TVAMC for at least 6 months following the prescription of divalproex or lamotrigine.

Exclusion Criteria:

Primary diagnosis of schizoaffective or schizophrenia during the evaluation period.
Prescription of divalproex and lamotrigine given concurrently during the observation period.
History of Dementia or cognitive disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451542

Sponsors and Collaborators

Tuscaloosa Research & Education Advancement Corporation

Investigators

Principal Investigator:

Lori L Davis, MD

Tuscaloosa Reseach and Education Advancement Corporation

More Information

Publications:

Vieta E, Rosa AR. Evolving trends in the long-term treatment of bipolar disorder. World J Biol Psychiatry. 2007;8(1):4-11.

ClinicalTrials.gov Identifier:	NCT00451542 History of Changes
Other Study ID Numbers:	0063
Study First Received:	March 21, 2007
Last Updated:	March 21, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by Tuscaloosa Research & Education Advancement Corporation:

Bipolar Disorder
Relapse
Retropspective

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012