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

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