Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: lamictal (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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).
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Time From Randomization to the Occurrence of a Bipolar Event (TOBE)
Secondary outcome: 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) Number of Participants Experiencing a Relapse/Recurrence to Depression, Mania/Hypomania, or Mixed Mood State Number of Participants Experiencing a Relapse/Recurrence Within the First 30, 90, and 180 Days in the Randomized Phase 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 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 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 Change From Randomization in the Quick Inventory of Depressive Symptomatology - Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Randomized Phase Change From Baseline in the Clinical Global Impressions - Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Open-Label Phase Change From Randomization in the Clinical Global Impressions - Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Randomized Phase Summary of Clinical Global Impressions - Bipolar - Improvement of Illness (CGI-BP [I]) Scores During Open-label Phase Summary of Clinical Global Impressions - Bipolar - Improvement of Illness (CGI-BP [I]) Scores During Randomized Phase 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 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 Change From Baseline in the Young Mania Rating Scale (YMRS) at Each Visit in the Open-Label Phase Change From Randomization in the Young Mania Rating Scale (YMRS) at Each Visit in the Randomized Phase Change From Baseline in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Open-Label Phase Change From Randomization in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Randomized Phase Change From Baseline in the Conners' Global Index - Parent Version (CGI-P) at Each Visit in the Open-Label Phase Change From Randomization in the Conners' Global Index - Parent Version (CGI-P) at Each Visit in the Randomized Phase.
Eligibility
Minimum age: 10 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Investigational Site, Dothan, Alabama 36305, United States
GSK Investigational Site, Scottsdale, Arizona 85252, United States
GSK Investigational Site, San Diego, California 92108, United States
GSK Investigational Site, Stanford, California 94304, United States
GSK Investigational Site, Washington, District of Columbia 20010, United States
GSK Investigational Site, Bradenton, Florida 34201, United States
GSK Investigational Site, Gainesville, Florida 32607, United States
GSK Investigational Site, Jacksonville, Florida 32216, United States
GSK Investigational Site, Orlando, Florida 32839, United States
GSK Investigational Site, Tampa, Florida 33613, United States
GSK Investigational Site, Winter Park, Florida 32789, United States
GSK Investigational Site, Smyrna, Georgia 30080, United States
GSK Investigational Site, Libertyville, Illinois 60048, United States
GSK Investigational Site, Naperville, Illinois 60563, United States
GSK Investigational Site, Indianapolis, Indiana 46202, United States
GSK Investigational Site, Overland Park, Kansas 66211, United States
GSK Investigational Site, Wichita, Kansas 67206, United States
GSK Investigational Site, Shreveport, Louisiana 71103, United States
GSK Investigational Site, Baltimore, Maryland 21208, United States
GSK Investigational Site, Boston, Massachusetts 02114, United States
GSK Investigational Site, Boston, Massachusetts 02115, United States
GSK Investigational Site, Springfield, Massachusetts 01199, United States
GSK Investigational Site, Worcester, Massachusetts 01655, United States
GSK Investigational Site, Rochester, Minnesota 55905, United States
GSK Investigational Site, St. Charles, Missouri 63304, United States
GSK Investigational Site, Lincoln, Nebraska 68526, United States
GSK Investigational Site, Piscataway, New Jersey 08854, United States
GSK Investigational Site, Albuquerque, New Mexico 87109, United States
GSK Investigational Site, Mount Kisco, New York 10549, United States
GSK Investigational Site, Stony Brook, New York 11794-8790, United States
GSK Investigational Site, Chapel Hill, North Carolina 27517, United States
GSK Investigational Site, Fargo, North Dakota 58104, United States
GSK Investigational Site, Cincinnati, Ohio 45219, United States
GSK Investigational Site, Cincinnati, Ohio 45229, United States
GSK Investigational Site, Cleveland, Ohio 44106, United States
GSK Investigational Site, Columbus, Ohio 43210, United States
GSK Investigational Site, Toledo, Ohio 43609, United States
GSK Investigational Site, Philadelphia, Pennsylvania 19104, United States
GSK Investigational Site, Dallas, Texas 75235, United States
GSK Investigational Site, Houston, Texas 77007, United States
GSK Investigational Site, Houston, Texas 77008, United States
GSK Investigational Site, Houston, Texas 77030, United States
GSK Investigational Site, Salt Lake City, Utah 84105, United States
GSK Investigational Site, Roanoke, Virginia 24013, United States
GSK Investigational Site, Kirkland, Washington 98033, United States
GSK Investigational Site, Seattle, Washington 98105, United States
Additional Information
Starting date: July 2008
Last updated: May 8, 2014
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