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

This is an interventional treatment trial for Bipolar Disorder focused on measuring Carbamazepine, Equetro, Bipolar I Disorder, Bipolar I Disorder in Children Read More

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