Quetiapine and Concerta in the Treatment for ADHD and Aggressive Behavior.
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Attention Deficit Disorder with Hyperactivity; Aggression
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this thirteen-week, open-label study is to test the hypothesis that
      quetiapine in combination with Oros methylphenidate will reduce aggressive symptoms in
      children and adolescents who have shown inadequate response to OROS methylphenidate alone.
    

Detailed description: 
      Informed consent will be obtained from the subject and parent or legal guardian before any
      study procedures begin. Study procedures will include the verification of inclusion and
      exclusion criteria, and completion of assessments and safety measures (physical examination,
      vital signs, adverse events and concomitant medication review, AIMS, laboratory tests, ECG,
      pregnancy test) as indicated in the Schedule of Events. All laboratory and electrocardiogram
      results must be reviewed by a physician before the subject returns for Visit 2.

      Study Period II (Visits 2-5)

      All subjects meeting entry criteria will initially receive Oros methylphenidate beginning at
      Visit 2. The Oros methylphenidate will be titrated over 3 visits according to the following
      schedule:

        -  Visit 2 dose of 18 mg QAM

        -  Visit 3 dose of 36mg QAM

        -  Visit 4 dose of 54mg QAM.

        -  At Visit 5, any subjects unable to tolerate continuation of the Oros methylphenidate
           dose of 54mg QAM or subjects that meet improvement criteria as defined above will be
           discontinued from the study. Subjects able to tolerate the daily dose of 54mg Oros
           methylphenidate and who do not meet improvement criteria at Visit 5 will begin receiving
           quetiapine in addition to continuing Oros methylphenidate at 54mg QAM for the balance of
           the study. The initial dose of quetiapine dispensed at Visit 5 will be 25mg QAM for one
           day with an increase to 25mg BID until Visit 6.

      At each visit safety and efficacy information will be completed according to the Schedule of
      Events.

      Study Period III (Visits 6-10) Quetiapine will be titrated at Visits 6 - 9 according to the
      parameters in the quetiapine dosing schedule and the completion of safety and efficacy
      measures listed in the Schedule of Events. A telephone follow-up with the parent or legal
      guardian will be made 7-9 days after Visit 8 for physician review of subject adverse events
      and safety.

      At visit 10 subjects will be given clinical recommendations for follow-up care from a
      physician investigator after completion of all study procedures (labs/EKG, vital signs,
      physical exam, AIMS, ADHD-RS-IV, CGI-I, CGI-S, RAAPP, MOAS, SNAP, CCPT)
    

Intervention name(s): Oros Methylphenidate; quetiapine
Intervention type(s): Drug; Drug
Intervention description(s): Oros methylphenidate will be titrated over 3 visits according to the following schedule:
Visit 2 dose of 18 mg QAM
Visit 3 dose of 36mg QAM
Visit 4 dose of 54mg QAM.; Quetiapine will be titrated according to the following schedule as determined by efficacy and safety assessments (See Table 1).
Table 1: Quetiapine Dosing Schedule (subject's required weight = 30-80 kg)
Visit 5 dose of 25mg BID
Visit 6 dose of 50mg BID
Visit 7 dose of 100mg BID
Visit 8 dose of 200mg BID
Visit 9 dose of 300mg BID
Efficacy: For any visit following Visit 5, dosage will remain stable if clinically significant improvement criteria are met.If subjects subsequently fail to meet clinically significant improvement criteria, dose increases will resume at the next level of the dosing schedule.
Other intervention name(s): Concerta; Seroquel
Intervention MeSH terms: Quetiapine Fumarate; Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD-Combined TypeDisruptive behavior Disorder