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The Young Adult and Pediatric Bipolar Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00350857
Recruitment Status : Completed
First Posted : July 11, 2006
Last Update Posted : February 20, 2014
Sponsor:
Information provided by (Responsible Party):
Validus Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 10, 2006
First Posted Date  ICMJE July 11, 2006
Last Update Posted Date February 20, 2014
Study Start Date  ICMJE July 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2007)
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. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2006)
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.
Change History Complete list of historical versions of study NCT00350857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2007)
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. [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2006)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Young Adult and Pediatric Bipolar Study
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bipolar I Disorder
Intervention  ICMJE Drug: Extended-Release Carbamazepine
Study Arms  ICMJE Active Comparator: Equetro active
Intervention: Drug: Extended-Release Carbamazepine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2014)
161
Original Enrollment  ICMJE
 (submitted: July 10, 2006)
225
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00350857
Other Study ID Numbers  ICMJE SPD417-311
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Validus Pharmaceuticals
Study Sponsor  ICMJE Validus Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Validus Pharmaceuticals
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP