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 disorderOccurrence 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
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