Clinical trial NCT00360126: An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Lamictal
lamotrigine
Open-Label Extension Study
Bipolar Disorder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 54 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Greenwich
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Everton Park
country: Australia
facility: GSK Investigational Site
state: Queensland
city: New Farm
country: Australia
facility: GSK Investigational Site
state: Queensland
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: