Divalproex vs. Lamotrigine for Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier:
NCT00451542
First received: March 21, 2007
Last updated: August 30, 2012
Last verified: August 2012
  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 3

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Time to Relapse During Treatment With Divalproex vs. Lamotrigine for Bipolar Disorder

Resource links provided by NLM:


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

Enrollment: 1000
Study Start Date: February 2006
Study Completion Date: February 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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
Sampling Method:   Non-Probability Sample
Study Population

Patients with Bipolar Disorder I or II who had a prescription of divalproex or lamotrigine.

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 divalproex).
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Lori Davis, MD, ACSO R&D, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00451542     History of Changes
Other Study ID Numbers: 0063
Study First Received: March 21, 2007
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Tuscaloosa Research & Education Advancement Corporation:
Bipolar Disorder
Relapse
Retrospective

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 20, 2014