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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00360126
First received: August 2, 2006
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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 Intervention Phase
Bipolar Disorder
Drug: lamotrigine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety Safety will be evaluated on an ongoing basis during the scheduled visits, either in the clinic or by telephone

Secondary Outcome Measures:
  • This study has no secondary outcome measures

Estimated Enrollment: 15
Study Start Date: October 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lamotrigine
    Other Name: lamotrigine
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360126

Locations
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00360126     History of Changes
Other Study ID Numbers: SCA104753
Study First Received: August 2, 2006
Last Updated: May 31, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Lamictal
lamotrigine
Open-Label Extension Study
Bipolar Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014