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

Bipolar Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360126
• Other study ID #: SCA104753
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2006
• Last updated: May 31, 2012
• Start date: October 2005
• Est. completion date: February 2007

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• lamotrigine

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Everton Park	Queensland
Australia	GSK Investigational Site	Greenwich	New South Wales
Australia	GSK Investigational Site	New Farm	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Safety will be evaluated on an ongoing basis during the scheduled visits, either in the clinic or by telephone
Secondary	This study has no secondary outcome measures