Status:
COMPLETED
An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder
Lead Sponsor:
GlaxoSmithKline
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or sterilised) or,
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00360126
Start Date
October 1 2005
End Date
February 1 2007
Last Update
March 30 2017
Active Locations (3)
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1
GSK Investigational Site
Greenwich, New South Wales, Australia, 2065
2
GSK Investigational Site
Everton Park, Queensland, Australia, 4053
3
GSK Investigational Site
New Farm, Queensland, Australia, 4005