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Bipolar Disorder Study for Men and Women | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Bipolar Disorder Study for Men and Women

Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression

NCT00056277•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must provide written and informed consent
•Diagnosis of Bipolar I Disorder and currently depressed for minimum of the previous 8 weeks
•Patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior

Exclusion Criteria

•Patients must not be suicidal
•Patients must not have a history or non-response to antidepressant treatment
•Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry
•Patients must not have had epilepsy or hypothyroidism

Locations (20)

GSK Investigational Site

Beverly Hills, California, United States

GSK Investigational Site

La Jolla, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Santa Ana, California, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Terre Haute, Indiana, United States

GSK Investigational Site

Shreveport, Louisiana, United States

GSK Investigational Site

Saint Charles, Missouri, United States

GSK Investigational Site

Princeton, New Jersey, United States

GSK Investigational Site

New York, New York, United States

Key Dates

Start Date

February 27, 2003

Primary Completion Date

August 1, 2005

Completion Date

December 14, 2005

Last Updated

April 7, 2017

Enrollment

150

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: April 7, 2017Data 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 Disorder Study for Men and Women

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