Special Drug Use Investigation for LAMICTAL Bipolar

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01428518
First received: September 1, 2011
Last updated: April 21, 2016
Last verified: April 2016
  Purpose

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.)


Condition Intervention
Bipolar Disorder
Drug: Lamotrigine tablets

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for LAMICTAL Bipolar

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of patients with any adverse drug reaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of skin disorder [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Occurrence of suicide-related event and self injurious behaviour [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Occurrence of harming others [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Occurrence of withdrawal symptoms after treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 1036
Study Start Date: November 2011
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with bipolar disorder
Patients with bipolar disorder prescribed lamotrigine tablets for the first time
Drug: Lamotrigine tablets
Administered according to the prescribing information in the locally approved label by the authorities.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428518

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01428518     History of Changes
Other Study ID Numbers: 115324 
Study First Received: September 1, 2011
Last Updated: April 21, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on July 28, 2016