Last updated on February 2018

DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bipolar Disorder
  • Age: Between 10 - 17 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Written, signed and dated informed consent from subject, parents or legal guardians.
  • Subject must be willing to participate for the duration of the study (8-10 months)
  • Subject must meet DSM-V criteria for a primary diagnosis of bipolar I disorder.
  • MINI KID administered and ruled out other psychiatric diagnosis.
  • ADHD Rating Scale-IV is ruled negative.
  • YMRS Score 20 or greater
  • CGI-S score of 4 or greater
  • CGI-I Global Evaluation score of 4 or less
  • Must be aged between 10 and 17 years
  • Male and non-pregnant, non-lactating females who agree to comply with contraceptive requirements
  • Functioning at an age appropriate level intellectually as deemed by the Investigator
  • Subject has no co-morbid conditions that would affect efficacy, safety or tolerability or in any way interfere with the subject's participation in the study
  • Subject, parents and legal guardians are able to and willing to comply with study procedures and restrictions
  • Must have a satisfactory medical assessment with no clinically significant abnormalities
  • Able to avoid grapefruit and grapefruit juice for the duration of the study

Exclusion Criteria:

  • Subject has a current controlled or uncontrolled co-morbid psychiatric that could interfere with clinical assessments or study conduct.
  • Naive subjects whose symptoms are being controlled on their prescribed medication(s) will not be eligible to participate.
  • History of lack of therapeutic response to an adequate trial of carbamazepine to treat bipolar I disorder
  • Believed by the Investigator to be acutely at risk for suicidal or violent behavior towards him/her or others, or a history of a suicide attempt requiring general medical intervention
  • Subject's bipolar diagnosis is believed secondary to traumatic injury or another general medical condition.
  • A history or known presence of clinically significant cardiovascular, hepatic, hematological, immunological (including human immunodeficiency virus, gastro-intestinal or renal disease or any other unstable medical illness that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments
  • 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
  • Currently hospitalized for the treatment of psychiatric symptoms.
  • Presence of any mental disorder due to a general medical condition
  • Presence of abnormal thyroid function that is not adequately treated in the opinion of the Investigator
  • Use of ECT, any investigational drug, CYP450 3A4 inhibitors, antidepressants, anxiolytics, sedative hypnotics, antipsychotics, mood stabilizers, ADHD medications, or clozapine in a specified time period prior to the initiation of the study
  • Use of any nutraceutical to include, but not limited to any over the counter herbal preparations e.g. Gingko Biloba, St John's Wort, Kava Kava and Ephedra.
  • Positive urine drug screen
  • History of alcohol or other substance abuse or dependence as defined by DSM-V (except caffeine or nicotine) within the last 6months
  • Female subjects with a positive pregnancy test or who are pregnant, lactating, who are less than 6 months post partum, or who cannot be relied upon to use adequate birth control
  • Subjects who have previously been enrolled in the Phase IV Multi-Center , Open-Label Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Acute Manic or Mixed Bipolar I Disorder and subsequently withdrawn
  • Subjects with a body weight of 65kg
  • Family of investigational site staff

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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