Special Drug Use Investigation for LAMICTAL Bipolar

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Lamotrigine tablets

• Registration Number: NCT01428518
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This post-marketing surveillance study is designed to collect and assess information on safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine clinical practice.

("LAMICTAL" is a trademark of the GlaxoSmithKline group of companies.)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-05
• Study Start: 2011-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1036

Inclusion Criteria

• Patients with bipolar disorder
• Patients treated with lamotrigine tablets for the first time

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with bipolar disorder	Lamotrigine tablets	Patients with bipolar disorder prescribed lamotrigine tablets for the first time

Primary Outcome Measures

Name	Time	Method
Number of patients with any adverse drug reaction	1 year

Secondary Outcome Measures

Name	Time	Method
Occurrence of skin disorder	1 year
Occurrence of suicide-related event and self injurious behaviour	1 year
Occurrence of harming others	1 year
Occurrence of withdrawal symptoms after treatment	1 year