Clinical trial NCT00350857: The Young Adult and Pediatric Bipolar Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar I Disorder
Lead sponsor: Validus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-07-11
Enrollment: 161
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Key Inclusion Criteria:

  1. DSM-IV diagnosis of bipolar I disorder, most recent episode manic or mixed.
  2. A lifetime history of bipolar disorder symptoms for at least 2 months.
  3. YMRS score greater than or equal to 16.
  4. CGI-S score greater than or equal to 4.
  5. Male or female outpatient aged between 10-17 years old inclusive at the time of consent.
  6. Functioning at an age-appropriate level intellectually, as deemed by the Investigator.
  7. 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.
  8. Must have a satisfactory medical assessment with no clinically significant and relevant abnormalities.

Exclusion Criteria:

* Key Exclusion Criteria:

  1. Current controlled or uncontrolled, co-morbid psychiatric diagnosis that could interfere with clinical assessments or study conduct.
  2. A history of lack of therapeutic response or hypersensitivity to the study drug.
  3. A greater than or equal to 50% reduction in YMRS between Screening and Baseline.
  4. Acutely at risk for suicidal or violent behavior or a history of suicide attempts requiring medical intervention.
  5. A history of aplastic anemia, agranulocytosis or bone marrow depression.
  6. A history of seizure disorder, other than a single childhood febrile seizure.
  7. A history of severe, unstable asthma.
  8. Current hospitalization for psychiatric symptoms.
  9. History of alcohol or other substance abuse or dependence.
  10. Pregnant or lactating females.
  11. Body weight less than or equal to 25 kg.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Altamonte Springs
country: United States
facility: 11 Shire Clinical Research Site
state: Florida
city: Fort Lauderdale
country: United States
facility: 17 Segal Institute for Clinical Research
state: Florida
city: Gainesville
country: United States
facility: 19 Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: 23 Shire Clinical Research Site
state: Florida
city: North Miami
country: United States
facility: 21 Scientific Clinical Research
state: Florida
city: Decatur
country: United States
facility: 14 Northlake Medical Research
state: Georgia
city: Eagle
country: United States
facility: 04 Mountain West Clinical Trials
state: Idaho
city: Libertyville
country: United States
facility: 25 Capstone Clinical Research
state: Illinois
city: Overland Park
country: United States
facility: 15 Psychiatric Associates
state: Kansas
city: Owensboro
country: United States
facility: 27 Owensboro Behavioral Care
state: Kentucky
city: Shreveport
country: United States
facility: 05 Brentwood Research Institute
state: Louisiana
city: Baltimore
country: United States
facility: 13 Pharmasite Research, Inc
state: Maryland
city: Rochester
country: United States
facility: 02 Finger Lakes Clinical Research
state: New York
city: Chapel Hill
country: United States
facility: 01 Nccacrf
state: North Carolina
city: Cincinnati
country: United States
facility: 06 University of Cincinnati, College of Medicine
state: Ohio
city: Cleveland
country: United States
facility: 09 Discovery and Wellness Center for Children
state: Ohio
city: Oklahoma City
country: United States
facility: 03 IPS Research
state: Oklahoma
city: Media
country: United States
facility: 26 Suburban Research Associates
state: Pennsylvania
city: Bellaire
country: United States
facility: 12 Claghorn-Lesem Research Clinic
state: Texas
city: Dallas
country: United States
facility: 07 Center for Pediatric Psychiatry
state: Texas
city: Houston
country: United States
facility: 24 Red Oak Psychiatry Associates
state: Texas
city: Lake Jackson
country: United States
facility: 10 RID Clinical Research, Inc
state: Texas
city: Midlothian
country: United States
facility: 08 Dominion Clinical Research
state: Virginia
city: Virginia Beach
country: United States
facility: 22 Brighton Research Group
state: Virginia
city: Milwaukee
country: United States
facility: 20 Shire Clinical Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: 16 Rogers Center for Research and Training
state: Wisconsin
Study officials:
References: