The Young Adult and Pediatric Bipolar Study
Information source: Validus Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar I Disorder
Intervention: Extended-Release Carbamazepine (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Validus Pharmaceuticals
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 10 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
19 Sarkis Clinical Trials, Gainesville, Florida 32607, United States
11 Shire Clinical Research Site, Altamonte Springs, Florida 32701, United States
17 Segal Institute for Clinical Research, Fort Lauderdale, Florida 33319, United States
21 Scientific Clinical Research, North Miami, Florida 33161, United States
23 Shire Clinical Research Site, Jacksonville, Florida 32256, 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
24 Red Oak Psychiatry Associates, Houston, Texas 77090, United States
10 RID Clinical Research, Inc, Lake Jackson, Texas 77566, United States
12 Claghorn-Lesem Research Clinic, Bellaire, Texas 77401, United States
07 Center for Pediatric Psychiatry, Dallas, Texas 75235, United States
08 Dominion Clinical Research, Midlothian, Virginia 23112, United States
22 Brighton Research Group, Virginia Beach, Virginia 23452, United States
16 Rogers Center for Research and Training, Milwaukee, Wisconsin 53227, United States
20 Shire Clinical Research Site, Milwaukee, Wisconsin 53201, United States
Additional Information
Starting date: July 2006
Ending date: May 2008
Last updated: October 4, 2007
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