Divalproex vs. Lamotrigine for Bipolar Disorder
Information source: Tuscaloosa Research & Education Advancement Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Tuscaloosa Research & Education Advancement Corporation Official(s) and/or principal investigator(s):
Lori L Davis, MD, Principal Investigator, Affiliation: Tuscaloosa Reseach and Education Advancement Corporation
Summary
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.
Clinical Details
Official title: Time to Relapse During Treatment With Divalproex vs. Lamotrigine for Bipolar Disorder
Study design: Natural History, Cross-Sectional, Defined Population, Retrospective Study
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
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related publications: Vieta E, Rosa AR. Evolving trends in the long-term treatment of bipolar disorder. World J Biol Psychiatry. 2007;8(1):4-11.
Starting date: February 2006
Ending date: February 2008
Last updated: March 21, 2007
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