The Young Adult and Pediatric Bipolar Study

Completed · Phase 4

Conditions studied: Bipolar I Disorder

In brief

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.

Key facts

Study ID: NCT00350857
Run by: Validus Pharmaceuticals
People needed: 161
Starts: 2006-07-01
Expected to finish: 2007-10-01
Last updated by the study team: 2014-02-20

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Key Inclusion Criteria:
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…

Key Exclusion Criteria:
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.

Where it is running

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

Full record on ClinicalTrials.gov

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