Bipolar Study in Adults at Least 18 Years of Age

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00067938

First received: September 3, 2003

Last updated: October 11, 2012

Last verified: October 2012

History of Changes

Purpose

Bipolar study of tolerability, clinical response and patient satisfaction

Condition	Intervention	Phase
Bipolar Disorder	Drug: lamotrigine	Phase 4


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]


Enrollment:	1200
Study Start Date:	August 2003
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1 Open label single arm study	Drug: lamotrigine Lamotrigine 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 300 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

No publications provided


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00067938 History of Changes
Other Study ID Numbers:	SCA40917
Study First Received:	September 3, 2003
Last Updated:	October 11, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:


bipolar disorder lamotrigine

Additional relevant MeSH terms:


Bipolar Disorder Affective Disorders, Psychotic Mental Disorders Mood Disorders Lamotrigine Anticonvulsants Calcium Channel Blockers Cardiovascular Agents Central Nervous System Agents Excitatory Amino Acid Agents	Excitatory Amino Acid Antagonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Sodium Channel Blockers Therapeutic Uses Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on March 01, 2015

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