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| Sponsor: | Indiana University School of Medicine |
|---|---|
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00550147 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity |
Drug: Oros Methylphenidate Drug: quetiapine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Study of Quetiapine Added to Oros Methylphenidate in the Treatment of ADHD and Aggressive Behavior |
| Enrollment: | 30 |
| Study Start Date: | February 2004 |
| Study Completion Date: | November 2005 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Oris Methylphenidate and Quetiapine
|
Drug: Oros Methylphenidate
Oros methylphenidate will be titrated over 3 visits according to the following schedule:
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 6 7 8 9 25mg BID 50mg BID 100mg BID 200mg BID 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. |
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have one DSM-IV aggressive feature of Conduct Disorder (CD) as rated on the K-SADS-PL including:
Exclusion Criteria:
Female subjects who are pregnant or who are breast-feeding as assessed at Visit 1.
Postmenarcheal sexually-active females who are not using a clinically acceptable method of birth control.
Subjects taking any medications that are not reviewed and approved by a physician investigator. Specific requirements include:
Contacts and Locations| United States, Indiana | |
| Riley Childrens Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | David Dunn, MD | Indiana University |
More Information
| ClinicalTrials.gov Identifier: | NCT00550147 History of Changes |
| Obsolete Identifiers: | NCT00198211 |
| Other Study ID Numbers: | NCT00198211 |
| Study First Received: | October 25, 2007 |
| Last Updated: | October 26, 2007 |
| Health Authority: | United States: Institutional Review Board |
|
ADHD-Combined TypeDisruptive behavior Disorder |
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate Quetiapine Dopamine Uptake Inhibitors Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |