Special Drug Use Investigation for LAMICTAL Bipolar

GlaxoSmithKline1,036 enrolled

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

OBSERVATIONAL

Enrollment

1,036

Conditions

Bipolar Disorder

Interventions

Lamotrigine tabletsDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with bipolar disorder * Patients treated with lamotrigine tablets for the first time Exclusion Criteria: * Not applicable

Outcomes

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

Data from ClinicalTrials.gov

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