Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
The Evaluation of Lamictal as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age
1 other identifier
interventional
301
1 country
46
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2008
Longer than P75 for phase_3
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 24, 2008
CompletedFirst Posted
Study publicly available on registry
July 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
June 4, 2014
CompletedJanuary 9, 2017
November 1, 2016
5.1 years
July 24, 2008
March 27, 2014
November 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time From Randomization to the Occurrence of a Bipolar Event (TOBE)
TOBE was defined by the first prescription of any additional pharmacotherapy to treat bipolar symptoms, increasing the dose(s) of the participants conventional bipolar medication(s), treatment with electroconvulsive therapy, or moving the participant to a more restricted environment for observation, safety, or treatment; or participant withdrawal from the study due to a bipolar-related adverse event (AE) or serious adverse event (SAE); or participants withdrawal from the study due to lack of efficacy as defined by rating scale threshold scores. TOBE was calculated using a log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).
From randomization until Week 36
Secondary Outcomes (21)
Time From Randomization to Withdrawal From the Study for Any Cause (TTW)
From randomization until withdrawal from the study for any cause (up to Week 36)
Time From Randomization to Intervention for a Mood Episode (TIME)
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)
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
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
From randomization up to Week 36
- +16 more secondary outcomes
Study Arms (2)
placebo
PLACEBO COMPARATORPlacebo Controlled
lamictal
EXPERIMENTALFlexible Dosing
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (46)
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 D.C., 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
Saint 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
Related Publications (1)
Findling RL, Chang K, Robb A, Foster VJ, Horrigan J, Krishen A, Wamil A, Kraus JE, DelBello M. Adjunctive Maintenance Lamotrigine for Pediatric Bipolar I Disorder: A Placebo-Controlled, Randomized Withdrawal Study. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):1020-1031.e3. doi: 10.1016/j.jaac.2015.09.017. Epub 2015 Oct 14.
PMID: 26598477DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2008
First Posted
July 28, 2008
Study Start
July 1, 2008
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
January 9, 2017
Results First Posted
June 4, 2014
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.