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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. Identifier: NCT00350857
Recruitment Status : Completed
First Posted : July 11, 2006
Last Update Posted : February 20, 2014
Information provided by (Responsible Party):
Validus Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: Extended-Release Carbamazepine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : July 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Equetro active Drug: Extended-Release Carbamazepine

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00350857

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Sponsors and Collaborators
Validus Pharmaceuticals

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Responsible Party: Validus Pharmaceuticals Identifier: NCT00350857     History of Changes
Other Study ID Numbers: SPD417-311
First Posted: July 11, 2006    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: November 2009
Additional relevant MeSH terms:
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Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers