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

February 13, 2017 updated by: GlaxoSmithKline

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.

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.

Study Overview

Status

Completed

Conditions

Bipolar Disorder

Intervention / Treatment

Drug: lamotrigine

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Greenwich, New South Wales, Australia, 2065
    - GSK Investigational Site
- Queensland
  - Everton Park, Queensland, Australia, 4053
    - GSK Investigational Site
  - New Farm, Queensland, Australia, 4005
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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:

non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or sterilised) or,
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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious Adverse Events (SAEs) Time Frame: Up to 54 weeks	An adverse event (AE) is defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event is therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Only SAEs were recorded and reported in this extension study.	Up to 54 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

August 2, 2006

First Submitted That Met QC Criteria