GSK: Protocol Summary for SCA102833

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Protocol Summary for SCA102833

Protocol Summary
Protocol Id:	SCA102833
Secondary Ids:
Title:	The Evaluation of Lamictal as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	yes
IND/IDE Grantor:	CDER
IND/IDE Number:	049,916
IND/IDE Serial Number:
Has Expanded Access?:	no
Study Type:	Interventional
Oversight Authority:	United States: Food and Drug Administration
Collaborators:
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 Description:
Record Verification Date:	January 2013
Status:	Active not recruiting
Why Study Stopped:
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2013
Study Completion Date Type:	Anticipated
Estimated Primary Completion Date:	September 2013
Primary Completion Date Type:	Anticipated
Primary Purpose:	treatment
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	yes
Masked Caregiver:	no
Masked Investigator:	yes
Masked Assessor:	no
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	The primary efficacy endpoint is the time from randomization to the occurence of a bipolar event. yes 52 weeks
Secondary Outcomes:	Time 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. yes 52 weeks
Conditions:	Bipolar Disorder
Keywords:	Bipolar I pediatric lamictal adolescent
Eligibility Criteria:	Click to view inclusion/exclusion 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.
Gender:	Both
Minimum Age:	10 Year
Maximum Age:	17 Year
Enrollment:	340
Enrollment Type:	Anticipated
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information United States (click to view all sites in United States) California (click to view) GSK Investigational Site San Diego, California, 92108; COMPLETED; GSK Investigational Site Stanford, California, 94305; RECRUITING; Georgia (click to view) GSK Investigational Site Smyrna, Georgia, 30080; RECRUITING; Kansas (click to view) GSK Investigational Site Overland Park, Kansas, 66211; RECRUITING; New Mexico (click to view) GSK Investigational Site Albuquerque, New Mexico, 87109; RECRUITING; Washington (click to view) GSK Investigational Site Kirkland, Washington, 98033; RECRUITING;

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Protocol Summary for SCA102833