Bipolar Disorder MedDRA version: 19.0 Level: HLT Classification code 10004938 Term: Bipolar disorders System Organ Class: 100000004873
Conditions
Interventions
Product Name: Lamictal
Pharmaceutical Form: Chewable/dispersible tablet
INN or Proposed INN: LAMOTRIGINE
CAS Number: 84057-84-1
Other descriptive name: LAMOTRIGINE
Concentration unit: mg milligram(s
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: 301 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy of LAMICTAL versus placebo in delaying the time to the occurrence of a bipolar event in subjects who have been responsive to open-label LAMICTAL treatment added to their conventional mono- or dual-bipolar therapy.;Primary end point(s): The primary efficacy endpoint is the time from randomization to the occurrence of a bipolar event (TOBE).;Timepoint(s) of evaluation of this end point: 36 Weeks;Secondary Objective: • To evaluate the safety and long-term tolerability of LAMICTAL compared to placebo. • To evaluate quality of life and satisfaction, as well as psychological, social, and school functioning in patients receiving LAMICTAL compared to placebo. • To evaluate the efficacy of LAMICTAL compared to placebo in the treatment of different bipolar I subtypes (i.e., manic/hypomanic, depressed, mixed). • To determine the proportion of child and adolescent subjects with bipolar I disorder who meet stabilization criteria during the Open-label Phase with LAMICTAL as add-on therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time from randomization to withdrawal from the study for any cause (TTW). - Time from randomization to intervention for a mood episode (TIME). - Time from randomization to intervention for depression (TIDep), mania/hypomania (TIMan), or a mixed episode (TIMix). - Proportion of subjects experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state. - Proportion of subjects experiencing a relapse/recurrence within the first 30, 90, and 180 days of the Randomized Phase. • Change from Baseline/Randomization in the Quick Inventory of Depressive Symptomatology – Clinician interview, semi-structured, adolescent version (QIDSA17-C) at each visit. • Change from Baseline/Randomization in the Quick Inventory of Depressive Symptomatology – self-report adolescent version (QIDS-A17-SR) at each visit. • Change from Baseline/Randomization in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at each visit. • Change in the Clinical Global Impressions – Bipolar, Improvement of Illness (CGIBP[ I]) score at each visit. • Proportion of subjects considered much improved or very much improved [defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGIBP[ I]), score of 1 or 2] at each visit compared to Baseline/Randomization. • Change from Baseline/Randomization in the Young Mania Rating Scale (YMRS) at each visit. • Change from Baseline/Randomization in the Parent Version of the Young Mania Rating Scale (P-YMRS) at each visit. • Change from Baseline/Randomization in the Conners’ Global Index – Parent Version (CGI-P) at each visit. Note: For endpoints noted as being the change from “Baseline/Randomization,” this means “change from Baseline” in the Open;Timepoint(s) of evaluation of this end point: 36 Weeks | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd.
Outcome results
None listed