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COMPLETEDPHASE4

Bipolar Study in Adults at Least 18 Years of Age

Lamictal for Use in Treatment of Bipolar Disorder In Adults. A Practical Clinical Assessment of Tolerability and Clinical Effectiveness.

NCT00067938•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

Bipolar study of tolerability, clinical response and patient satisfaction

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of bipolar I disorder.
•Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
•If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.

Exclusion Criteria

•Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.
•Presence of untreated thyroid disease.
•Patient is actively suicidal or homicidal.
•Patient has history of severe hepatic or renal insufficiency.
•Patient is currently participating in another clinical trial.

Locations (308)

GSK Investigational Site

Albertville, Alabama, United States

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Fairhope, Alabama, United States

GSK Investigational Site

Huntsville, Alabama, United States

GSK Investigational Site

Tuscaloosa, Alabama, United States

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

Key Dates

Start Date

August 1, 2003

Primary Completion Date

August 1, 2004

Completion Date

August 1, 2004

Last Updated

September 1, 2016

Enrollment

1,200

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

lamotrigine

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 1, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bipolar Study in Adults at Least 18 Years of Age

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

CBT-CP for Veterans With SMI

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Early Intervention for Youth at High Risk for Bipolar Disorder