- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00393042
Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR
Sleep and Tolerability of Extended Release Dexmethylphenidate vs. Mixed Amphetamine Salts: A Double Blind, Placebo Controlled Study (SAT STUDY)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60608
- University of Illinois at Chicago
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Northbrook, Illinois, United States, 60062
- Northbrook HALP Clinic/ADHD Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Focalin XR then Adderall XR
Subjects are given the Focalin XR first (dexmethylphenidate) for four weeks with a randomized placebo week followed by Adderall XR (mixed amphetamine salts) for four weeks with a randomized placebo week.
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10, 20, 25-30 mg.
Other Names:
10, 20, 25-30
Other Names:
randomized placebo week during each 4 week period
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Experimental: Adderall XR then Focalin XR
Subjects are given the Adderall XR (mixed amphetamine salts) for four weeks with a randomized placebo week followed by Focalin XR first (dexmethylphenidate) for four weeks with a randomized placebo week.
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10, 20, 25-30 mg.
Other Names:
10, 20, 25-30
Other Names:
randomized placebo week during each 4 week period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks.
Time Frame: 8-10 weeks
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Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment.
These computerized wristwatch-like devices collect data generated by movements.
They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine.
One-minute epochs were used to analyze actigraphic sleep sata.
Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses.
For each 1-min epoch, the total sum of activity counts were computed.
If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking.
If it fell below that threshold, then it was considered sleep.
The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.
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8-10 weeks
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Sleep Duration
Time Frame: 8-10 weeks
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Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment.
These computerized wristwatch-like devices collect data generated by movements.
They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine.
One-minute epochs were used to analyze actigraphic sleep sata.
Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses.
For each 1-min epoch, the total sum of activity counts were computed.
If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking.
If it fell below that threshold, then it was considered sleep.The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.
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8-10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADHD Parent Rating Scale-IV
Time Frame: completed weekly over 8-10 weeks
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Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms.
The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms.
The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales.
The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.
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completed weekly over 8-10 weeks
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Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms
Time Frame: 8-10 weeks
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Three variations of the DAT 1 gene were observed, the 9/9 allele, the 9/10 allele and the 10/10 allele.
The ADHD Rating Scale (ADHD-RS) and Clinical Global Impressions - Severity (CGI-S) measures were used to evaluate how the DAT 1 gene allele type altered the efficacy of the medication.
The DAT 1 genotype did not predict differential response to Focalin XR or Adderall XR so the dose levels of each drug was combined to examine how the genotype interacted with the dose level.
The ADHD-RS evaluates the severity of the participant's ADHD symptoms and includes two subscales: Inattention and Hyperactivity/Impulsivity. Both subscale scores range from 0 to 27 with a higher score representing more severe symptoms.
The subscales are summed to calculate the total score which can range from 0 to 54.
The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.
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8-10 weeks
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Clinical Global Impression - Severity
Time Frame: 8-10 weeks
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The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.
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8-10 weeks
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Weiss Functional Impairment Rating Scale (WFIRS)
Time Frame: 8-10 weeks
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The WFIRS consists of 50 questions where respondents are asked to rate their child's functional impairment.
The items of the WFIRS are scored on a four point Likert-type rating scale: 0 (never or not at all), 1 (sometimes or somewhat), 2 (often or much) or 3 (very often or very much) and aggregated to produce six domain scores: Family (ranges between 0-24), Learning or School (ranges between 0-33), Self-Concept (ranges between 0-15), Social Activities (ranges between 0-27), Life Skills (ranges between 0-36), and Risky Activities (ranges between 0-42).
The subscales are scored by summing the responses in the subsection.
The Total score is the sum of all the responses and it ranges between 0-150.
The higher the score in each of the subscales the more impairment is recorded, this is also true for the total score.
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8-10 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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)
Publications and helpful links
General Publications
- Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8. doi: 10.1097/00004583-199707000-00021.
- Charach A, Figueroa M, Chen S, Ickowicz A, Schachar R. Stimulant treatment over 5 years: effects on growth. J Am Acad Child Adolesc Psychiatry. 2006 Apr;45(4):415-21. doi: 10.1097/01.chi.0000199026.91699.20.
- Schachar R, Jadad AR, Gauld M, Boyle M, Booker L, Snider A, Kim M, Cunningham C. Attention-deficit hyperactivity disorder: critical appraisal of extended treatment studies. Can J Psychiatry. 2002 May;47(4):337-48. doi: 10.1177/070674370204700404.
- Pelham WE, Aronoff HR, Midlam JK, Shapiro CJ, Gnagy EM, Chronis AM, Onyango AN, Forehand G, Nguyen A, Waxmonsky J. A comparison of ritalin and adderall: efficacy and time-course in children with attention-deficit/hyperactivity disorder. Pediatrics. 1999 Apr;103(4):e43. doi: 10.1542/peds.103.4.e43.
- Stein MA, Sarampote CS, Waldman ID, Robb AS, Conlon C, Pearl PL, Black DO, Seymour KE, Newcorn JH. A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder. Pediatrics. 2003 Nov;112(5):e404. doi: 10.1542/peds.112.5.e404.
- Stein MA, Waldman ID, Charney E, Aryal S, Sable C, Gruber R, Newcorn JH. Dose effects and comparative effectiveness of extended release dexmethylphenidate and mixed amphetamine salts. J Child Adolesc Psychopharmacol. 2011 Dec;21(6):581-8. doi: 10.1089/cap.2011.0018. Epub 2011 Dec 2.
- Santisteban JA, Stein MA, Bergmame L, Gruber R. Effect of extended-release dexmethylphenidate and mixed amphetamine salts on sleep: a double-blind, randomized, crossover study in youth with attention-deficit hyperactivity disorder. CNS Drugs. 2014 Sep;28(9):825-33. doi: 10.1007/s40263-014-0181-3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Amphetamine
- Adderall
- Dexmethylphenidate Hydrochloride
Other Study ID Numbers
- CRIT124E US15
- 2006-0423
- 2006-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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