Divalproex vs. Lamotrigine for Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Time to Relapse During Treatment With Divalproex vs. Lamotrigine for Bipolar Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00451542
• Other study ID #: 0063
• Status: Terminated
• Phase: N/A
• First received: March 21, 2007
• Last updated: April 25, 2017
• Start date: February 1, 2006
• Est. completion date: February 1, 2008

Study information

• Verified date: April 2017
• Source: Tuscaloosa Research & Education Advancement Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: February 1, 2008
• Est. primary completion date: May 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tuscaloosa Research & Education Advancement Corporation

References & Publications (1)

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