Overview

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

Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Anticonvulsants
Lamotrigine
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