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Special Drug Use Investigation for LAMICTAL Bipolar

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: Lamotrigine tablets (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.)

Clinical Details

Official title: Special Drug Use Investigation for LAMICTAL Bipolar

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Number of patients with any adverse drug reaction

Secondary outcome:

Occurrence of skin disorder

Occurrence of suicide-related event and self injurious behaviour

Occurrence of harming others

Occurrence of withdrawal symptoms after treatment

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with bipolar disorder

- Patients treated with lamotrigine tablets for the first time

Exclusion Criteria:

- Not applicable

Locations and Contacts

Additional Information

Starting date: November 2011
Last updated: March 26, 2015

Page last updated: August 23, 2015

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