The Young Adult and Pediatric Bipolar Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Validus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00350857
First received: July 10, 2006
Last updated: February 19, 2014
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Bipolar I Disorder
Drug: Extended-Release Carbamazepine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Validus Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: July 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Equetro active Drug: Extended-Release Carbamazepine

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350857

  Show 26 Study Locations
Sponsors and Collaborators
Validus Pharmaceuticals
  More Information

No publications provided

Responsible Party: Validus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00350857     History of Changes
Other Study ID Numbers: SPD417-311
Study First Received: July 10, 2006
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014