Special Drug Use Investigation for LAMICTAL Bipolar

Overview

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.)

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: January 2016

Interventions

• Drug: Lamotrigine tablets
  • Administered according to the prescribing information in the locally approved label by the authorities.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

• Number of patients with any adverse drug reaction
  • Time Frame: 1 year

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

• Patients with bipolar disorder – Patients treated with lamotrigine tablets for the first time Exclusion Criteria:

• Not applicable

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • GlaxoSmithKline
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • GSK Clinical Trials, Study Director, GlaxoSmithKline