Special Drug Use Investigation for LAMICTAL Bipolar

Bipolar Disorder Clinical Trial

Official title:

Special Drug Use Investigation for LAMICTAL Bipolar

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01428518
• Other study ID #: 115324
• Status: Active, not recruiting
• Phase: N/A
• First received: September 1, 2011
• Last updated: March 26, 2015
• Start date: November 2011
• Est. completion date: October 2015

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with bipolar disorder

• Patients treated with lamotrigine tablets for the first time

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with any adverse drug reaction		1 year	No
Secondary	Occurrence of skin disorder		1 year	No
Secondary	Occurrence of suicide-related event and self injurious behaviour		1 year	No
Secondary	Occurrence of harming others		1 year	No
Secondary	Occurrence of withdrawal symptoms after treatment		1 year	No