Last updated: 11/07/2018 18:54:59
Lamictal as Add-on treatment for Bipolar I disorder in pediatric patients
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: The Evaluation of Lamictal as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age
Trial description: The study will be a multi-center, parallel, group, placebo control, double-blind, randomized controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged 10 to 17 years) diagnosed with Bipolar I disorder. The study consists of 4 phases: Screen (approximately 2 weeks), Open label phase (up to 18 weeks), Randomized phase (up to 36 weeks) and Taper and follow-up phase (up to 4 weeks).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Time from randomization to the occurrence of a bipolar event (TOBE)
Timeframe: From randomization until Week 36
Secondary outcomes:
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
Interventions:
Drug: lamictal
Enrollment:
301
Observational study model:
Not applicable
Primary completion date:
2013-07-08
Time perspective:
Not applicable
Clinical publications:
Robert L. Findling, Kiki Chang, Adelaide Robb, Vicki J. Foster, Joseph Horrigan, Alok Krishen, Art Wamil, John E. Kraus, Melissa DelBello. Adjunctive maintenance lamotrigine for pediatric bipolar I disorder: a placebo-controlled, randomized withdrawal study. J Am Acad Child Adolesc Psychiatry.2015;54(12):1020-1031.
Medical condition
Bipolar Disorder
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
July 2008 to August 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
10 - 17 years
Accepts healthy volunteers
No
- Inclusion Criteria
- Subject is male or female between the ages of 10 and 17 years, inclusive.
Inclusion and exclusion criteria
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. 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)
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Seattle, Washington, United States, 98105
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66211
Status
Study Complete
Location
GSK Investigational Site
Mount Kisco, New York, United States, 10549
Status
Study Complete
Location
GSK Investigational Site
Piscataway, New Jersey, United States, 08854
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63304
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92108
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20010
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32607
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
Status
Study Complete
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stony Brook, New York, United States, 11794-8790
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01199
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
Location
GSK Investigational Site
Naperville, Illinois, United States, 60563
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87109
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21208
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68526
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27517
Status
Study Complete
Location
GSK Investigational Site
Bradenton, Florida, United States, 34201
Status
Study Complete
Location
GSK Investigational Site
Worcester, Massachusetts, United States, 01655
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
Stanford, California, United States, 94304
Status
Study Complete
Location
GSK Investigational Site
Toledo, Ohio, United States, 43609
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orlando, Florida, United States, 32839
Status
Study Complete
Location
GSK Investigational Site
Roanoke, Virginia, United States, 24013
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85252
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84105
Status
Study Complete
Location
GSK Investigational Site
Kirkland, Washington, United States, 98033
Status
Study Complete
Location
GSK Investigational Site
Libertyville, Illinois, United States, 60048
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-07-08
Actual study completion date
2013-07-08
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.
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