Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Intervention: quetiapine
Intervention description: 2.5 - 5.0mg/kg PO BID quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: children; bipolar disorder; quetiapine; preschoolers

Summary:

      This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of
      Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar
      spectrum disorder. This is an exploratory, pilot study, seeking to determine whether
      Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric
      bipolar and bipolar spectrum disorder in this age group. The study results will be used to
      generate hypotheses for a larger randomized controlled clinical trial with explicit
      hypotheses and sufficient statistical power.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, 4-6 years of age.

          -  Subjects must have a DSM-IV diagnosis of bipolar I, bipolar II disorder or bipolar
             spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with
             or without psychotic features) according to the DSM-IV based on clinical assessment
             and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders
             and Schizophrenia Epidemiological Version). Bipolar spectrum disorder (or
             sub-threshold bipolar disorder) is operationalized as having severe mood disturbance,
             which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria
             B (only require 2 items for elation category and 3 for irritability).

          -  Subjects and their legal representative must have a level of understanding sufficient
             to communicate intelligently with the investigator and study coordinator, and to
             cooperate with all tests and examinations required by the protocol.

          -  Subjects and their legal representative must be considered reliable.

          -  Each subject and his/her authorized legal representative must understand the nature of
             the study. The subject's authorized legal representative must sign an informed consent
             document.

          -  Subjects must have an initial score on the Young Mania Rating Scale (Y-MRS) total
             score of at least 20.

          -  Subject must be able to participate in mandatory blood draws.

          -  Subjects with comorbid Attention Deficit Hyperactivity Disorder (ADHD), Oppositional
             Defiant Disorder (ODD), Conduct Disorder (CD), anxiety and depressive disorders will
             be allowed to participate in the study provided they do not meet for any of the
             exclusionary criteria.

          -  For concomitant stimulant therapy used to treat ADHD, subjects must have been on a
             stable dose of the medication for 1 month prior to study enrollment. The dose of the
             stimulant therapy will not change throughout the duration of the study.

        Exclusion Criteria:

          -  Investigator and his/her immediate family; defined as the investigator's spouse,
             parent, child, grandparent, or grandchild.

          -  Serious, unstable illness including hepatic, renal, gastroenterological, respiratory,
             cardiovascular (including ischemic heart disease), endocrinologic, neurologic,
             immunologic, or hematologic disease.

          -  Uncorrected hypothyroidism or hyperthyroidism.

          -  History of severe allergies or multiple adverse drug reactions.

          -  Non-febrile seizures without a clear and resolved etiology.

          -  Leukopenia or history of leukopenia without a clear and resolved etiology.

          -  Judged clinically to be at serious suicidal risk.

          -  Any other concomitant medication with primarily central nervous system activity other
             than specified in Concomitant Medication portion of the protocol.

          -  A non-responder or a history of intolerance to an adequate trial of Quetiapine(2
             months or more at an adequate dose) as determined by the clinician.

          -  Current diagnosis of schizophrenia.

          -  Non English speaking subjects will not be allowed into the study for the following
             reasons: a) the assessment instruments are not available and have not been adequately
             standardized in other languages; b) our clinical trials facility is located in
             Cambridge and not in the MGH main campus without the availability of translators; c)
             psychiatric questionnaires and evaluations are taxing and adding the complexity of a
             translator has the potential to make the patient experience even more exhausting.