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Special Drug Use Investigation for Lamictal® (Lamotrigine) Bipolar

This study is not yet open for participant recruitment.
Verified March 2012 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01428518
First received: September 1, 2011
Last updated: March 8, 2012
Last verified: March 2012
History of Changes
  Purpose

This post-marketing surveillance study is designed to collect and assess information on safety and efficacy of lamotrigine tablets in Japanese patients with bipolar disorder.

("LAMICTAL" is a trademark of the GlaxoSmithKline group of companies.)


Condition
Bipolar Disorder

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for Lamictal® (Lamotrigine) Bipolar

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Lamotrigine
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Japanese patients with any adverse event [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of skin disorder [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Occurrence of suicide-related event and self injurious behaviour [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Occurrence of harming others [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Occurrence of withdrawal symptoms after treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: November 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Japanese patients with bipolar disorder prescribed lamotrigine tablets for the first time

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not applicable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428518

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01428518     History of Changes
Other Study ID Numbers: 115324
Study First Received: September 1, 2011
Last Updated: March 8, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013