Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients

Overview[ - collapse ][ - ]

Purpose 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).
ConditionBipolar Disorder
InterventionDrug: lamictal
PhasePhase 3
SponsorGlaxoSmithKline
Responsible PartyGlaxoSmithKline
ClinicalTrials.gov IdentifierNCT00723450
First ReceivedJuly 24, 2008
Last UpdatedJanuary 30, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateJuly 24, 2008
Last Updated DateJanuary 30, 2014
Start DateJuly 2008
Estimated Primary Completion DateAugust 2013
Current Primary Outcome MeasuresThe primary efficacy endpoint is the time from randomization to the occurence of a bipolar event. [Time Frame: 52 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome MeasuresTime from randomization to withdrawal from the study for any cause. Time from randomization to intervention for a mood episode. Time from randomization to intervention for depression, mania/hypomania, or a mixed episode. [Time Frame: 52 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleLamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
Official TitleThe Evaluation of Lamictal as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age
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).
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionBipolar Disorder
InterventionDrug: lamictal
Flexible Dosing
Other Names:
lamictal
Study Arm (s)
  • Placebo Comparator: placebo
    Placebo Controlled
  • Experimental: lamictal
    Flexible Dosing

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment340
Estimated Completion DateAugust 2013
Estimated Primary Completion DateAugust 2013
Eligibility 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.
GenderBoth
Ages10 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00723450
Other Study ID NumbersSCA102833
Has Data Monitoring CommitteeNo
Information Provided ByGlaxoSmithKline
Study SponsorGlaxoSmithKline
CollaboratorsNot Provided
Investigators Study Director: GSK Clinical Trials GlaxoSmithKline
Verification DateJanuary 2014

Locations[ + expand ][ + ]

GSK Investigational Site
Dothan, Alabama, United States, 36305
GSK Investigational Site
Scottsdale, Arizona, United States, 85252
GSK Investigational Site
San Diego, California, United States, 92108
GSK Investigational Site
Stanford, California, United States, 94304
GSK Investigational Site
Washington, District of Columbia, United States, 20010
GSK Investigational Site
Bradenton, Florida, United States, 34201
GSK Investigational Site
Gainesville, Florida, United States, 32607
GSK Investigational Site
Jacksonville, Florida, United States, 32216
GSK Investigational Site
Orlando, Florida, United States, 32839
GSK Investigational Site
Tampa, Florida, United States, 33613
GSK Investigational Site
Winter Park, Florida, United States, 32789
GSK Investigational Site
Smyrna, Georgia, United States, 30080
GSK Investigational Site
Libertyville, Illinois, United States, 60048
GSK Investigational Site
Naperville, Illinois, United States, 60563
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
GSK Investigational Site
Overland Park, Kansas, United States, 66211
GSK Investigational Site
Wichita, Kansas, United States, 67206
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
GSK Investigational Site
Baltimore, Maryland, United States, 21208
GSK Investigational Site
Boston, Massachusetts, United States, 02114
GSK Investigational Site
Boston, Massachusetts, United States, 02115
GSK Investigational Site
Springfield, Massachusetts, United States, 01199
GSK Investigational Site
Worcester, Massachusetts, United States, 01655
GSK Investigational Site
Rochester, Minnesota, United States, 55905
GSK Investigational Site
St. Charles, Missouri, United States, 63304
GSK Investigational Site
Lincoln, Nebraska, United States, 68526
GSK Investigational Site
Piscataway, New Jersey, United States, 08854
GSK Investigational Site
Albuquerque, New Mexico, United States, 87109
GSK Investigational Site
Mount Kisco, New York, United States, 10549
GSK Investigational Site
Stony Brook, New York, United States, 11794-8790
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27517
GSK Investigational Site
Fargo, North Dakota, United States, 58104
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
GSK Investigational Site
Cleveland, Ohio, United States, 44106
GSK Investigational Site
Columbus, Ohio, United States, 43210
GSK Investigational Site
Toledo, Ohio, United States, 43609
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
GSK Investigational Site
Dallas, Texas, United States, 75235
GSK Investigational Site
Houston, Texas, United States, 77008
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Houston, Texas, United States, 77007
GSK Investigational Site
Salt Lake City, Utah, United States, 84105
GSK Investigational Site
Roanoke, Virginia, United States, 24013
GSK Investigational Site
Kirkland, Washington, United States, 98033
GSK Investigational Site
Seattle, Washington, United States, 98105