Clinical trial NCT00550147
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD-Combined TypeDisruptive behavior Disorder
Sponsor: Indiana University School of Medicine
Start date: 2004-02-01; Completion date: 2005-11-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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)

Arms: arm 1: Oros Methylphenidate and Quetiapine
Interventions: intervention 1: Oros Methylphenidate intervention 2: quetiapine
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents: