Bipolar Disorder Study for Men and Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-27

Study Completion Date

2005-12-14

Brief Summary

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

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Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type OTHER

lamotrigine

Intervention Type DRUG

Interventions

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lamotrigine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Beverly Hills, California, United States

Site Status

GSK Investigational Site

La Jolla, California, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

Santa Ana, California, United States

Site Status

GSK Investigational Site

Marietta, Georgia, United States

Site Status

GSK Investigational Site

Terre Haute, Indiana, United States

Site Status

GSK Investigational Site

Shreveport, Louisiana, United States

Site Status

GSK Investigational Site

Saint Charles, Missouri, United States

Site Status

GSK Investigational Site

Princeton, New Jersey, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Pleasantville, New York, United States

Site Status

GSK Investigational Site

Raleigh, North Carolina, United States

Site Status

GSK Investigational Site

Brecksville, Ohio, United States

Site Status

GSK Investigational Site

Cincinnati, Ohio, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Eugene, Oregon, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

GSK Investigational Site

Columbia, South Carolina, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Brown Deer, Wisconsin, United States

Site Status

Countries

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United States

References

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Hashimoto Y, Kotake K, Watanabe N, Fujiwara T, Sakamoto S. Lamotrigine in the maintenance treatment of bipolar disorder. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD013575. doi: 10.1002/14651858.CD013575.pub2.

Reference Type DERIVED

PMID: 34523118 (View on PubMed)

Study Documents

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