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An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00360126
Recruitment Status : Completed
First Posted : August 3, 2006
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):

Brief Summary:
The precursor study (SCA101469) was an open-label, prospective multicentre study in adult subjects diagnosed with bipolar disorder consisting of 36 weeks treatment with lamotrigine. The current study is to provide 12 months post study access to open-label lamotrigine for participants of the SCA101469 study.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: lamotrigine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Assess the Safety of Lamotrigine in Subjects With Bipolar Disorder, Who Are in Remission Following a Manic/Hypomanic Index Episode or a Depressive Index Episode.
Study Start Date : October 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Lamotrigine

Primary Outcome Measures :
  1. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 54 weeks ]
    An adverse event (AE) is defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event is therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Only SAEs were recorded and reported in this extension study.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

  • completed 32 weeks of open label treatment in study SCA101469 and, in the investigators opinion, has responded to lamotrigine therapy
  • male or female subject

A female is eligible to enter and participate in this study if she is of:

  1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or sterilised) or,
  2. child-bearing potential, has a negative urine pregnancy test at screening, and agrees to one of the following contraceptive methods:

    • Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for a time interval after completion of premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 5 half-lives or longer if the pharmacodynamic profile of the investigational drug warrants a longer time period); or,
    • Sterilisation of male partner; or,
    • Implants of levonorgestrel; or,
    • Injectable progestogen; or,
    • Oral contraceptive (combined or progestogen only); or,
    • Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or,
    • Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year; or,
    • Barrier method only if used in combination with any of the above acceptable methods.

      • willing and able to give written informed consent to participate in the study.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  • subject experienced a 'mood episode' during participation in study SCA101469, or since completing participation in study SCA101469.
  • participation in a clinical drug trial other than SCA101469 within the past 30 days or previous participation in this clinical study
  • known hypersensitivity to lamotrigine
  • in the investigator's judgement, the subject poses a current serious suicidal or homicidal risk, or has made a suicide attempt within the past 6 months.
  • combination of carbamazepine and valproate
  • concurrent lamotrigine therapy, other than that commenced in study SCA101469
  • current or history of substance abuse
  • diagnosis of epilepsy
  • diagnosis or history of an obsessive-compulsive disorder, social phobia, or eating disorder
  • significant cardiac, renal, cerebrovascular, or hepatic condition; no significant abnormalities in the laboratory tests or ECG recording performed during study SCA101469.
  • unable to understand or implement instructions
  • unresolved drug related adverse event or serious adverse event occurring in study SCA101469

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 identifier (NCT number): NCT00360126

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Australia, New South Wales
GSK Investigational Site
Greenwich, New South Wales, Australia, 2065
Australia, Queensland
GSK Investigational Site
Everton Park, Queensland, Australia, 4053
GSK Investigational Site
New Farm, Queensland, Australia, 4005
Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline Identifier: NCT00360126    
Other Study ID Numbers: SCA104753
First Posted: August 3, 2006    Key Record Dates
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017
Last Verified: February 2017
Keywords provided by GlaxoSmithKline:
Open-Label Extension Study
Bipolar Disorder
Additional relevant MeSH terms:
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Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers