Bipolar Study in Adults at Least 18 Years of Age - Tabular View

Tracking Information

First Received Date ^ICMJE

September 3, 2003

Last Updated Date

June 25, 2007

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

The primary endpoint will be the rate of rash during 12 weeks.

Change History

Complete list of historical versions of study NCT00067938 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severity and Improvement scores.

Descriptive Information

Brief Title ^ICMJE

Bipolar Study in Adults at Least 18 Years of Age

Official Title ^ICMJE

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

Brief Summary

Bipolar study of tolerability, clinical response and patient satisfaction

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: lamotrigine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00067938

Responsible Party

Study ID Numbers ^ICMJE

SCA40917

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

GSK Clinical Trial, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP