NCT00451542

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

March 21, 2007

Last Update Submit

April 25, 2017

Conditions

Bipolar Disorder

Keywords

Bipolar DisorderRelapseRetrospective

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1080/15622970601083280.

    PMID: 17366344BACKGROUND

MeSH Terms

Conditions

Bipolar DisorderRecurrence

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lori L Davis, MD

    Tuscaloosa Reseach and Education Advancement Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ACSO R&D

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 23, 2007

Study Start

February 1, 2006

Primary Completion

May 1, 2007

Study Completion

February 1, 2008

Last Updated

April 27, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share