Bipolar Study in Adults at Least 18 Years of Age

This study has been completed.

First Received on September 3, 2003. Last Updated on March 25, 2011 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00067938

Purpose

Bipolar study of tolerability, clinical response and patient satisfaction

Condition	Intervention	Phase
Bipolar Disorder	Drug: lamotrigine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label Study of Tolerability, Clinical Response, and Satisfaction in Adult Bipolar I Subjects Optimizing Initiation of Therapy Using Administration of Dermatological Precautions and LAMICTAL Titration Packs

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The primary endpoint will be the rate of rash during 12 weeks. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores. [ Time Frame: 12 Weeks ]

Enrollment:	1059
Study Start Date:	August 2003
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Intervention Details:

Other Name: lamotrigine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067938

Show 299 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00067938 History of Changes
Other Study ID Numbers:	SCA40917
Study First Received:	September 3, 2003
Last Updated:	March 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

bipolar disorder
lamotrigine

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012