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). |
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Condition | Bipolar Disorder |
Intervention | Drug: lamictal |
Phase | Phase 3 |
Sponsor | GlaxoSmithKline |
Responsible Party | GlaxoSmithKline |
ClinicalTrials.gov Identifier | NCT00723450 |
First Received | July 24, 2008 |
Last Updated | January 30, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | July 24, 2008 |
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Last Updated Date | January 30, 2014 |
Start Date | July 2008 |
Estimated Primary Completion Date | August 2013 |
Current Primary Outcome Measures | The 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 Measures | 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. [Time Frame: 52 weeks] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients |
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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 |
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 | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Bipolar Disorder |
Intervention | Drug: lamictal Flexible Dosing Other Names: lamictal |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 340 |
Estimated Completion Date | August 2013 |
Estimated Primary Completion Date | August 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. |
Gender | Both |
Ages | 10 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00723450 |
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Other Study ID Numbers | SCA102833 |
Has Data Monitoring Committee | No |
Information Provided By | GlaxoSmithKline |
Study Sponsor | GlaxoSmithKline |
Collaborators | Not Provided |
Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
GSK Investigational Site | Dothan, Alabama, United States, 36305 |
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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 |