Special Drug Use Investigation for LAMICTAL Bipolar

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01428518

Enrollment

1036

Registered

2011-09-05

Start date

2011-11-30

Completion date

2016-01-31

Last updated

2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

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.)

Interventions

DRUGLamotrigine tablets

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Not applicable

Design outcomes

Primary

Measure	Time frame
Number of patients with any adverse drug reaction	1 year

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026