NCT01428518

Brief 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.)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,036

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

4.2 years

First QC Date

September 1, 2011

Last Update Submit

April 21, 2016

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Number of patients with any adverse drug reaction

    1 year

Secondary Outcomes (4)

  • Occurrence of skin disorder

    1 year

  • Occurrence of suicide-related event and self injurious behaviour

    1 year

  • Occurrence of harming others

    1 year

  • Occurrence of withdrawal symptoms after treatment

    1 year

Study Arms (1)

Patients with bipolar disorder

Patients with bipolar disorder prescribed lamotrigine tablets for the first time

Drug: Lamotrigine tablets

Interventions

Lamotrigine tabletsDRUG

Administered according to the prescribing information in the locally approved label by the authorities.

Patients with bipolar disorder

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TriazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 5, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 25, 2016

Record last verified: 2016-04