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Special Drug Use Investigation for LAMICTAL Bipolar

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ClinicalTrials.gov Identifier: NCT01428518
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.)


Condition or disease Intervention/treatment
Bipolar Disorder Drug: Lamotrigine tablets

Study Type : Observational
Actual Enrollment : 1036 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for LAMICTAL Bipolar
Study Start Date : November 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. Number of patients with any adverse drug reaction [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Occurrence of skin disorder [ Time Frame: 1 year ]
  2. Occurrence of suicide-related event and self injurious behaviour [ Time Frame: 1 year ]
  3. Occurrence of harming others [ Time Frame: 1 year ]
  4. Occurrence of withdrawal symptoms after treatment [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428518


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01428518     History of Changes
Other Study ID Numbers: 115324
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016

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