The Young Adult and Pediatric Bipolar Study
A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder.
1 other identifier
interventional
161
1 country
26
Brief Summary
To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2006
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 10, 2006
CompletedFirst Posted
Study publicly available on registry
July 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFebruary 20, 2014
November 1, 2009
1.3 years
July 10, 2006
February 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability as assessed by the occurrence of treatment emergent adverse events and evaluations of clinical laboratory values, physical examinations, vital signs and ECG data after 6 months of treatment.
6 months
Secondary Outcomes (1)
Reduction of bipolar symptoms as assessed by the Young Mania Rating Scale (YMRS), Clinical Global Impressions Scale (CGI) and Children's Depression Rating Scale (CDRS-S) after 6 months of treatment.
6 months
Study Arms (1)
Equetro active
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- DSM-IV diagnosis of bipolar I disorder, most recent episode manic or mixed.
- A lifetime history of bipolar disorder symptoms for at least 2 months.
- YMRS score greater than or equal to 16.
- CGI-S score greater than or equal to 4.
- Male or female outpatient aged between 10-17 years old inclusive at the time of consent.
- Functioning at an age-appropriate level intellectually, as deemed by the Investigator.
- The subject has no co-morbid illness that could affect efficacy, safety, or tolerability or in any way interfere with the subject's participation in the study.
- Must have a satisfactory medical assessment with no clinically significant and relevant abnormalities.
You may not qualify if:
- Current controlled or uncontrolled, co-morbid psychiatric diagnosis that could interfere with clinical assessments or study conduct.
- A history of lack of therapeutic response or hypersensitivity to the study drug.
- A greater than or equal to 50% reduction in YMRS between Screening and Baseline.
- Acutely at risk for suicidal or violent behavior or a history of suicide attempts requiring medical intervention.
- A history of aplastic anemia, agranulocytosis or bone marrow depression.
- A history of seizure disorder, other than a single childhood febrile seizure.
- A history of severe, unstable asthma.
- Current hospitalization for psychiatric symptoms.
- History of alcohol or other substance abuse or dependence.
- Pregnant or lactating females.
- Body weight less than or equal to 25 kg.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
11 Shire Clinical Research Site
Altamonte Springs, Florida, 32701, United States
17 Segal Institute for Clinical Research
Fort Lauderdale, Florida, 33319, United States
19 Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
23 Shire Clinical Research Site
Jacksonville, Florida, 32256, United States
21 Scientific Clinical Research
North Miami, Florida, 33161, United States
14 Northlake Medical Research
Decatur, Georgia, 30333, United States
04 Mountain West Clinical Trials
Eagle, Idaho, 83616, United States
25 Capstone Clinical Research
Libertyville, Illinois, 60048, United States
15 Psychiatric Associates
Overland Park, Kansas, 66211, United States
27 Owensboro Behavioral Care
Owensboro, Kentucky, 42303, United States
05 Brentwood Research Institute
Shreveport, Louisiana, 71101, United States
13 Pharmasite Research, Inc
Baltimore, Maryland, 21208, United States
02 Finger Lakes Clinical Research
Rochester, New York, 14618, United States
01 Nccacrf
Chapel Hill, North Carolina, 27514, United States
06 University of Cincinnati, College of Medicine
Cincinnati, Ohio, 45267, United States
09 Discovery and Wellness Center for Children
Cleveland, Ohio, 44106, United States
03 IPS Research
Oklahoma City, Oklahoma, 73103, United States
26 Suburban Research Associates
Media, Pennsylvania, 19063, United States
12 Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401, United States
07 Center for Pediatric Psychiatry
Dallas, Texas, 75235, United States
24 Red Oak Psychiatry Associates
Houston, Texas, 77090, United States
10 RID Clinical Research, Inc
Lake Jackson, Texas, 77566, United States
08 Dominion Clinical Research
Midlothian, Virginia, 23112, United States
22 Brighton Research Group
Virginia Beach, Virginia, 23452, United States
20 Shire Clinical Research Site
Milwaukee, Wisconsin, 53201, United States
16 Rogers Center for Research and Training
Milwaukee, Wisconsin, 53227, United States
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2006
First Posted
July 11, 2006
Study Start
July 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
February 20, 2014
Record last verified: 2009-11