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

Condition(s) targeted: Bipolar Disorder

Intervention: lamotrigine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: This study has no secondary outcome measures

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

GSK Investigational Site, Greenwich, New South Wales 2065, Australia

GSK Investigational Site, Everton Park, Queensland 4053, Australia

GSK Investigational Site, New Farm, Queensland 4005, Australia

Starting date: October 2005
Last updated: May 31, 2012