Status:
COMPLETED
The Young Adult and Pediatric Bipolar Study
Lead Sponsor:
Validus Pharmaceuticals
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
10-17 years
Phase:
PHASE4
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
- Key
- 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.
Exclusion
- Key
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00350857
Start Date
July 1 2006
End Date
October 1 2007
Last Update
February 20 2014
Active Locations (26)
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1
11 Shire Clinical Research Site
Altamonte Springs, Florida, United States, 32701
2
17 Segal Institute for Clinical Research
Fort Lauderdale, Florida, United States, 33319
3
19 Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
4
23 Shire Clinical Research Site
Jacksonville, Florida, United States, 32256