Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR
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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 the investigators 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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Sleep and Tolerability of Extended Release Dexmethylphenidate vs. Mixed Amphetamine Salts: A Double Blind, Placebo Controlled Study (SAT STUDY) |
- Number of minutes to sleep onset as determined by actigraph and sleep diary over 8 weeks.Ratings of side effects, mood. [ Time Frame: 8-10 weeks ] [ Designated as safety issue: Yes ]
- Ratings of ADHD symptoms along with parent, self report and clinician ratings of mood, tolerability, stimulant side effects, functional outcomes (e.g. family conflicts), and vital signs over a period of 8 weeks. [ Time Frame: 8-10 weeks ] [ Designated as safety issue: Yes ]
- The number of 10 repeat alleles of DAT1 as correlated with ADHD symptoms and CGI-S ratings. [ Time Frame: First week ] [ Designated as safety issue: No ]
- Family Conflicts [ Time Frame: 8-10 weeks ] [ Designated as safety issue: No ]
- ADHD Symptoms [ Time Frame: 8-10 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 77 |
| Study Start Date: | January 2006 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Focalin XR first, then Adderall XR
|
Drug: Dexmethylphenidate XR
10, 20, 25-30 mg.
Drug: Mixed Amphetamine Salts, ER
10, 20, 25-30
Other Name: Adderall XR
Drug: placebo
randomized placebo during each period
|
|
Experimental: 2
Adderall XR first, then Focalin XR
|
Drug: Dexmethylphenidate XR
10, 20, 25-30 mg.
Drug: Mixed Amphetamine Salts, ER
10, 20, 25-30
Other Name: Adderall XR
Drug: placebo
randomized placebo during each period
|
Detailed Description:
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:
- Any ADHD subtype, determined by KSADS interview (Kaufman, Birmaher et al. 1997). Comorbidity will likewise be allowed, to ensure representation.
- Signed informed consent and assent
- Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating is greater than or equal to 4
- Findings on physical exam, laboratory studies, vital signs, and ECG are judged to be normal for age
- Pulse and blood pressure are within 95% of age and gender mean
- Able to complete study instruments and swallow capsules
- Willing to commit to the entire visit schedule for the study, including at least one visit to UIC Medical Center.
Exclusion Criteria:
- Previous diagnosis of mental retardation
- Non-responder to either medication at the doses offered in the study in an adequate trial
- Must not have experienced disabling adverse effects with either medication
- Concomitant psychotropic medications are required or medications which might have a CNS effect
- Any other medical condition which represents a contraindication for either treatment is present
- History of alcohol or drug abuse in the past 3 months, or a positive urinary toxic screen on initial evaluation that is not explained by a time-limited medical circumstance
- Females of childbearing age who are sexually active, do not use acceptable birth control (double protection method), and after counseling, are unwilling to do so
- History of allergic reactions to multiple medications
- A history of psychosis
- Diagnosis of bipolar disorder
Contacts and Locations| United States, Illinois | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60608 | |
| Northbrook HALP Clinic/ADHD Research Center | |
| Northbrook, Illinois, United States, 60062 | |
| 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
Publications:
| Responsible Party: | Mark A Stein Ph.D., University of Illinois at Chicago |
| ClinicalTrials.gov Identifier: | NCT00393042 History of Changes |
| Other Study ID Numbers: | CRIT124E US15, 2006-0423, 2006-04 |
| Study First Received: | October 25, 2006 |
| Last Updated: | September 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Illinois:
|
Attention Deficit Hyperactivity Disorder sleep side effects stimulants |
Additional relevant MeSH terms:
|
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 Amphetamine Methamphetamine Adderall Methylphenidate Central Nervous System Stimulants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013