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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00360126
• Date of registration: 02/08/2006
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder
• Scientific 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.
• Date of first enrolment: October 2005
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00360126
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bipolar Disorder

Intervention(s)

Drug: lamotrigine

Primary Outcome(s)

Number of Participants With Serious Adverse Events (SAEs) [Time Frame: Up to 54 weeks]

Secondary ID(s)

SCA104753

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00360126