Divalproex vs. Lamotrigine for Bipolar Disorder
This study has been completed.
Information provided by (Responsible Party):
Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
First received: March 21, 2007
Last updated: August 30, 2012
Last verified: August 2012
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.
||Time Perspective: Retrospective
||Time to Relapse During Treatment With Divalproex vs. Lamotrigine for Bipolar Disorder
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2007 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||19 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with Bipolar Disorder I or II who had a prescription of divalproex or lamotrigine.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451542
Tuscaloosa Research & Education Advancement Corporation
||Lori L Davis, MD
||Tuscaloosa Reseach and Education Advancement Corporation
||Lori Davis, MD, ACSO R&D, Tuscaloosa Research & Education Advancement Corporation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 21, 2007
||August 30, 2012
||United States: Institutional Review Board
Keywords provided by Tuscaloosa Research & Education Advancement Corporation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Affective Disorders, Psychotic
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents