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| Sponsors and Collaborators: |
University of Illinois Novartis |
|---|---|
| Information provided by: | University of Illinois |
| ClinicalTrials.gov Identifier: | NCT00393042 |
Purpose
The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications.
This research is being done because we do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood.
It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Dexmethylphenidate XR Drug: Mixed Amphetamine Salts, ER Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Dose Comparison, Crossover Assignment, Pharmacodynamics Study |
| Official Title: | Sleep and Tolerability of Extended Release Dexmethylphenidate vs. Mixed Amphetamine Salts: A Double Blind, Placebo Controlled Study (SAT STUDY) |
| Estimated Enrollment: | 70 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | May 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Focalin XR first, then Adderall XR
|
Drug: Dexmethylphenidate XR
10, 20, 25-30 mg.
Drug: Mixed Amphetamine Salts, ER
10, 20, 25-30
Drug: placebo
randomized placebo during each period
|
|
2: Experimental
Adderall XR first, then Focalin XR
|
Drug: Dexmethylphenidate XR
10, 20, 25-30 mg.
Drug: Mixed Amphetamine Salts, ER
10, 20, 25-30
Drug: placebo
randomized placebo during each period
|
ADHD is often treated with stimulant medications, which have demonstrated short-term efficacy in numerous trials. However, treatment is often discontinued prematurely. Although ADHD often persists through adolescence, approximately half of all children who are treated with a stimulant medication discontinue treatment within one year (Charach, Ickowicz et al. 2004). Presumably, tolerability and treatment compliance are highly related to the side effect profile of stimulant medications (Schachar, Jadad et al. 2002). Sleep problems, particularly insomnia, are frequently associated with ADHD and are often exacerbated by stimulant medications, particularly at higher doses. Other frequent stimulant side effects are decreased appetite and mood lability (dysphoria/euphoria). Little is known about the relative effects of different stimulant formulations and dosages (i.e amphetamine, methylphenidate, dexmethylphenidate) on sleep and tolerability. There is some preliminary data with short acting stimulants suggesting a higher prevalence of sleep and appetite problems with amphetamine relative to mph (Pelham, Aronoff et al. 1999). Several studies indicate that sleep and other stimulant side effects are dose related (Stein, Sarampote et al. 2003), although this has not been found in all studies. Moreover, it is unclear if there are differences between long-acting amphetamine and methylphenidate based stimulants in their side effect profile and tolerability. Thus, we will directly compare these two long acting stimulant medications on their side effect profile and tolerability, including measures of sleep, mood, and evening behavior (e.g., family conflicts). The recently developed extended release formulation of dexmethylphenidate will be compared to one of the most common treatments for ADHD, extended release formulation of mixed amphetamine salts. The subject population will be older children and adolescents (10-17) with ADHD who are most likely to be treated with moderate to higher dose levels of stimulant medications and can complete all self-report measures.
Eligibility| Ages Eligible for Study: | 9 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mark A Stein, PhD | 312-996-5797 | mstein@psych.uic.edu |
| Contact: Lauren R Maul, MA | 312-355-3319 | lmaul@psych.uic.edu |
| United States, Illinois | |
| University of Illinois at Chicago | Not yet recruiting |
| Chicago, Illinois, United States, 60608 | |
| Contact: Mark A Stein, PhD 312-996-5797 mstein@psych.uic.edu | |
| Contact: Lauren R Maul, MA (312) 355-3319 lmaul@psych.uic.edu | |
| Principal Investigator: Mark A Stein, PhD | |
| Sub-Investigator: Elizabeth Charney, MD | |
| Northbrook HALP Clinic/ADHD Research Center | Recruiting |
| Northbrook, Illinois, United States, 60062 | |
| Contact: Mark A Stein, PhD 312-996-5797 mstein@psych.uic.edu | |
| Contact: Lauren R Maul, MA 312-355-3319 lmaul@psych.uic.edu | |
| Principal Investigator: Mark A Stein, PhD | |
| Sub-Investigator: Elizabeth Charney, PhD | |
| Principal Investigator: | Mark A Stein, PhD | University of Illinois-Chicago; Hyperactivity, Attention and Learning Problems Clinic (HALP) |
| Principal Investigator: | Elizabeth Charney, MD | University of Illinois-Chicago, Hyperactivity, Attention, and Learning Problems Clinic (HALP) |
| Study Director: | Lauren R Maul, MA | University of Illinois-Chicago |
More Information
| Responsible Party: | University of Illinois at Chicago ( Mark A Stein Ph.D. ) |
| Study ID Numbers: | CRIT124E US15, 2006-0423, 2006-04 |
| Study First Received: | October 25, 2006 |
| Last Updated: | February 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00393042 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Attention Deficit Hyperactivity Disorder sleep side effects stimulants |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Adderall Attention Deficit and Disruptive Behavior Disorders Methylphenidate Central Nervous System Stimulants Dyskinesias Signs and Symptoms Methamphetamine |
Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents Amphetamine Peripheral Nervous System Agents |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Adderall Physiological Effects of Drugs Methylphenidate Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood |
Hyperkinesis Sympathomimetics Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Dyskinesias Pharmacologic Actions Methamphetamine Autonomic Agents Neurologic Manifestations Amphetamine Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
