Lamictal as Add-on treatment for Bipolar I disorder in pediatric patients
Trial overview
Time from randomization to the occurrence of a bipolar event (TOBE)
Timeframe: From randomization until Week 36
Time from randomization to withdrawal from the study for any cause (TTW)
Timeframe: From randomization until withdrawal from the study for any cause (up to Week 36)
Time from randomization to intervention for a mood episode (TIME)
Timeframe: From randomization until intervention administered for a mood episode (up to Week 36)
Time from randomization to intervention for depression (TIDep), mania/hypomania (TIMan), or a mixed episode (TIMix)
Timeframe: From randomization until intervention administered for depression, mania/hypomania or a mixed episode (up to Week 36)
Number of participants experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state
Timeframe: From randomization until a relapse/recurrence to depression, mania/hypomania, or mixed mood state (up to Week 36)
Number of participants experiencing a relapse/recurrence within the first 30, 90, and 180 days in the Randomized Phase
Timeframe: From randomization up to Week 36
Change from Baseline in the Quick Inventory of Depressive Symptomatology – Clinician interview, semi-structured, adolescent version (QIDS- A17-C) at each visit in the Open-Label Phase
Timeframe: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18
Change from Randomization in the Quick Inventory of Depressive Symptomatology – Clinician interview, semi-structured, adolescent version (QIDS- A17-C) at each visit in the Randomized Phase
Timeframe: Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36
Change from Baseline in the Quick Inventory of Depressive Symptomatology – self-report adolescent version (QIDS-A17-SR) at each visit in the Open-Label Phase
Timeframe: Baseline and Weeks 4, 8, 12, 16, and 18
Change from Randomization in the Quick Inventory of Depressive Symptomatology – self-report adolescent version (QIDS-A17-SR) at each visit in the Randomized Phase
Timeframe: Randomization and Weeks 8, 16, 24, 32, and 36
Change from Baseline in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at each visit in the Open-Label Phase
Timeframe: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18
Change from Randomization in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at each visit in the Randomized Phase
Timeframe: Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36
Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores during Open-label Phase
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18
Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores during Randomized Phase
Timeframe: Randomization weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32 and 36
Number of participants considered much improved or very much improved [defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), score of 1 or 2] at each visit compared to Baseline in the Open-Label Phase
Timeframe: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18
Number of participants considered much improved or very much improved [defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), score of 1 or 2] at each visit compared to Randomization in the Randomized Phase
Timeframe: Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36
Change from Baseline in the Young Mania Rating Scale (YMRS) at each visit in the Open-Label Phase
Timeframe: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18
Change from Randomization in the Young Mania Rating Scale (YMRS) at each visit in the Randomized Phase
Timeframe: Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36
Change from Baseline in the Parent Version of the Young Mania Rating Scale (P-YMRS) at each visit in the Open-Label Phase
Timeframe: Baseline and Weeks 4, 8, 12, 16, and 18
Change from Randomization in the Parent Version of the Young Mania Rating Scale (P-YMRS) at each visit in the Randomized Phase
Timeframe: Randomization and Weeks 8, 16, 24, 32, and 36
Change from Baseline in the Conners’ Global Index – Parent Version (CGI-P) at each visit in the Open-Label Phase
Timeframe: Baseline and Weeks 4, 8, 12, 16, and 18
Change from Randomization in the Conners’ Global Index – Parent Version (CGI-P) at each visit in the Randomized Phase.
Timeframe: Randomization and Weeks 8, 16, 24, 32, and 36
Participation criteria
- Inclusion Criteria
- Subject is male or female between the ages of 10 and 17 years, inclusive.
- Inclusion Criteria
- Subject is male or female between the ages of 10 and 17 years, inclusive.
- Subject has a diagnosis of bipolar I disorder and is currently experiencing a manic/hypomanic, depressed, or mixed mood episode
- Subject is currently receiving a stable treatment regimen.
- Subject is living with his/her custodial parent(s) or legal guardian(s) and has contact with them on a daily basis. Exclusion Criteria
- Subject has been diagnosed with a primary Axis I disorder (with the exception of bipolar I disorder, ADHD, anxiety disorders, oppositional defiant disorder, or conduct disorder) or any Axis II disorder.
- Subject currently has signs or symptoms of psychosis or a history of psychosis within the previous four weeks.
- Subject has been diagnosed with epilepsy, autism, Asperger’s syndrome, or Tourette’s syndrome.
- Subject has experienced a serious rash, such as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis, or a rash otherwise requiring hospitalization.
- Subject has experienced a rash related to prior LAMICTAL use, or for whom LAMICTAL treatment was discontinued for clinically significant safety reasons.
- Subject has received any antidepressant medication, or atomoxetine, during the four weeks prior to the Screen Visit.
- Subject has initiated psychotherapy within 2 months prior to the Screen Visit, or plans to initiate psychotherapy during the trial.
- Subject in the 10-12 year old age group has a Body Mass Index (BMI) less than or equal 15 or greater than or equal to 30; a subject in the 13-17 year old age group has a BMI less than or equal to 17 or greater than or equal to 34.
- Subject tests positive for illicit drug use at the Screen Visit, has a history of alcohol or substance abuse or dependence (other than nicotine dependence) within the past three months, or has a positive blood alcohol level at the Screen Visit.
- Subject, in the investigator’s judgment, poses a current homicidal or serious suicidal risk, has made a suicide attempt within the twelve months preceding the Screen Visit, has ever been homicidal.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.