Bipolar Study in Adults at Least 18 Years of Age

Phase 4

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: lamotrigine

• Registration Number: NCT00067938
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Bipolar study of tolerability, clinical response and patient satisfaction

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2003-09-03
• Study First Submitted QC: 2003-09-04
• Study First Posted: 2003-09-05
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	lamotrigine	Open label single arm study

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the rate of rash during 12 weeks.	12 Weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 West Allis, Wisconsin, United States