Special Drug Use Investigation for LAMICTAL Bipolar

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.)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Not applicable

Treatment and study plan

Lamotrigine tablets

Drug

Administered according to the prescribing information in the locally approved label by the authorities.

Primary outcomes

Number of patients with any adverse drug reaction

Time frame: 1 year

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Sep 5, 2011
Registry last updated: Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed