Special Drug Use Investigation for LAMICTAL Bipolar

NCT ID: NCT01428518

Last Updated: 2016-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1036 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-01-31

Brief Summary

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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.)

Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with bipolar disorder

Patients with bipolar disorder prescribed lamotrigine tablets for the first time

Lamotrigine tablets

Intervention Type DRUG

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

Interventions

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Lamotrigine tablets

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not applicable
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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115324

Identifier Type: -

Identifier Source: org_study_id

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