Bipolar Disorder
Conditions
Keywords
Lamictal, lamotrigine, Open-Label Extension Study, Bipolar Disorder
Brief 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.
Interventions
DRUGlamotrigine
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 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. |
Countries
Australia
Participant flow
Recruitment details
A total of 11 participants were enrolled and randomized from 13 October 2005 to 12 February 2007.
Pre-assignment details
Participants who had completed 32 weeks treatment period in study SCA101469 were enrolled in this extension study.
Participants by arm
| Arm | Count |
|---|---|
| Lamotrigine Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Lamotrigine |
|---|---|
| Age, Continuous | 45.64 Years STANDARD_DEVIATION 3.28 |
| Region of Enrollment Australia | 11 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Number of Participants With Serious Adverse Events (SAEs)
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.
Time frame: Up to 54 weeks
Population: All subject population consisted of all participants enrolled into the study and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lamotrigine | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |