Quetiapine and Concerta in the Treatment for ADHD and Aggressive Behavior.
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|ClinicalTrials.gov Identifier: NCT00550147|
Recruitment Status : Completed
First Posted : October 29, 2007
Results First Posted : May 13, 2015
Last Update Posted : May 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity||Drug: Oros Methylphenidate Drug: quetiapine||Phase 2|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study of Quetiapine Added to Oros Methylphenidate in the Treatment of ADHD and Aggressive Behavior|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||November 2005|
Oros Methylphenidate and Quetiapine
Drug: Oros Methylphenidate
Oros methylphenidate will be titrated over 3 visits according to the following schedule:
Other Name: Concerta
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)
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 Name: Seroquel
- RAAPP: Rating of Aggression Against People and/or Property Scale [ Time Frame: See Arm/Group - Repeated Measures ]The RAAPP is a global rating scale of aggression that is completed by a clinician based on interview and observation data. It is scored from 1 (no aggression reported) to 5 (intolerable behavior).
- CGI-S: Clinical Global Improvement Scale [ Time Frame: See Arm/Group - Repeated Measures ]The CGI-S is a 1-7 investigator rating of overall severity of target behavioral symptoms, which will be completed at each visit as a secondary efficacy measure of global behavioral functioning. A score of 1 indicates "normal, not ill at all" and a score of 7 indicates "among the most extremely ill patients".
- Modified Overt Aggression Scale (MOAS) [ Time Frame: See arm/group - repeated measures ]The Modified Overt Aggression Scale (MOAS) is a clinician-rated scale of aggressive outbursts experienced in the past week. Weightings are assigned for severity and frequency of aggression. MOAS total severity score will be completed as a secondary efficacy measure of aggressive behavior. The range for the MOAS is 0-235. A score of 0 indicates "no aggression" and a score of 235 indicates "the most severe and frequent aggressive outbursts".
- Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale [ Time Frame: See arm/group - repeated measures analysis ]The Swanson, Nolan and Pelham (SNAP-IV) is a 90-item, parent-completed questionnaire consisting of symptoms of ADHD, aggression, depression, and mania. Parents rate each item from 0(not at all) to 3 (very much) based on their child's behavior during the past week. The scores from the Oppositional-Defiant Disorder section of this questionnaire will be used as secondary efficacy measures of parent-reported aggressive behavior. These scores range from 0-24.
- Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version) [ Time Frame: See Arm/Group - repeated measures ]The Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent:Inv) (Faries, Yalcin, Harder, & Heiligenstein, 2001) is an interviewer-administered semi structured interview with the parent, focusing on the 18 DSM-IV symptoms. Ratings are made on a 0 (never or rarely) to 3 (very often) scale. The range of the ADHDRS-IV is 0-54. A zero (0) scores indicates no ADHD symptoms and 54 indicates most severe ADHD symptoms. The ADHDRS-IV-Parent:Inv provides an overall severity score, symptom count, and ADHD diagnosis for the child.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550147
|United States, Indiana|
|Riley Childrens Hospital|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||David Dunn, MD||Indiana University|