Attention Deficit Hyperactivity DisorderPhase 3NCT00393042

Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR

A Phase 3 study testing Dexmethylphenidate and Mixed Amphetamine Salts, ER in people with Attention Deficit Hyperactivity Disorder, run by Seattle Children's Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 9 to 17 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder
What is being tested?: Dexmethylphenidate and Mixed Amphetamine Salts, ER
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 77 participants
Where: 2 sitesUnited States
Study dates: Jan 2006to Feb 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Illinois at Chicago
Chicago, Illinois, 60608
Northbrook HALP Clinic/ADHD Research Center
Northbrook, Illinois, 60062

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Attention Deficit Hyperactivity Disorder
Being tested: Dexmethylphenidate, Mixed Amphetamine Salts, ER, placebo
Keywords: Attention Deficit Hyperactivity Disorder, sleep, side effects, stimulants
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmethylphenidateDrug
Also called Focalin XR
10, 20, 25-30 mg.
Mixed Amphetamine Salts, ERDrug
Also called Adderall XR
10, 20, 25-30
placeboDrug
randomized placebo week during each 4 week period

Study groups in NCT00393042
Study group	Role	What they receive
Focalin XR then Adderall XR	Experimental	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. Receives: Drug: Dexmethylphenidate; Drug: Mixed Amphetamine Salts, ER; Drug: placebo
Adderall XR then Focalin XR	Experimental	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. Receives: Drug: Dexmethylphenidate; Drug: Mixed Amphetamine Salts, ER; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks.
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.
Measured: 8-10 weeks
Sleep Duration
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.
Measured: 8-10 weeks

Secondary outcomes (4)

ADHD Parent Rating Scale-IV
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.
Measured: completed weekly over 8-10 weeks
Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms
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.
Measured: 8-10 weeks
Clinical Global Impression - Severity
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.
Measured: 8-10 weeks
Weiss Functional Impairment Rating Scale (WFIRS)
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.
Measured: 8-10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Feb 2009

First posted26 Oct 2006 (estimated)
Study startJan 2006
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00393042
Sponsor's protocol ID: CRIT124E US15
Other IDs: 2006-0423, 2006-04
Status last verified: Mar 2017
First submitted: 25 Oct 2006
Last updated: 19 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 9204677
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.
PubMed 16601646
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.
PubMed 12025432
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.
PubMed 10103335
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.
PubMed 14595084
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.
PubMed 22136094
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.
PubMed 25056567

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep and Tolerability of Extended Release Dexmethylphenidate vs. Mixed Amphetamine Salts: A Double Blind, Placebo Controlled Study (SAT STUDY)
ClinicalTrials.gov ID: NCT00393042
Acronym / sponsor ID: CRIT124E US15
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder, sleep, side effects, stimulants
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Seattle Children's HospitalUniversity, hospital or other
Collaborators: Novartis
Study start: Jan 2006
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 26 Oct 2006 (estimated)
Results: Posted 19 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Focalin XR then Adderall XR	Experimental	Drug: Dexmethylphenidate, Drug: Mixed Amphetamine Salts, ER, Drug: placeboSubjects 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.
Adderall XR then Focalin XR	Experimental	Drug: Dexmethylphenidate, Drug: Mixed Amphetamine Salts, ER, Drug: placeboSubjects 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.

Who may qualify

Ages: 9 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexmethylphenidateAlso: Focalin XR10, 20, 25-30 mg.	Drug	Adderall XR then Focalin XR, Focalin XR then Adderall XR
Mixed Amphetamine Salts, ERAlso: Adderall XR10, 20, 25-30	Drug	Adderall XR then Focalin XR, Focalin XR then Adderall XR
placeborandomized placebo week during each 4 week period	Drug	Adderall XR then Focalin XR, Focalin XR then Adderall XR

Primary outcome

Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks.
Time frame: 8-10 weeks
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.
Sleep Duration
Time frame: 8-10 weeks
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.

4 secondary outcomes

ADHD Parent Rating Scale-IV
Time frame: completed weekly over 8-10 weeks
Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms
Time frame: 8-10 weeks
Clinical Global Impression - Severity
Time frame: 8-10 weeks
Weiss Functional Impairment Rating Scale (WFIRS)
Time frame: 8-10 weeks

Results and safety

Results posted to the registry on 19 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Focalin XR Then Adderall XR	31	26
Adderall XR Then Focalin XR	33	27

Primary outcome: Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks.

Time frame: 8-10 weeks. Mean (Standard Deviation). Unit: HHMM.SS

Measure	Placebo n = 37	10mg of Either Focalin XR or Adderall XR n = 37	20mg of Either Focalin XR or Adderall XR n = 37	25/30mg of Either Focalin XR or Adderall XR n = 37	Adderall XR All Dose Levels n = 37	Focalin XR All Dose Levels n = 37
Sleep start time	2249 (0012.19)	2304 (0010.40)	2319 (0012.21)	2325 (0011.17)	2309 (0011.05)	2309 (0011.19)
Sleep End time	0742 (0015.36)	0728 (0009.54)	0735 (0010.46)	0732 (0011.09)	0735 (0010.40)	0734 (0010.04)

Population analysed: Subjects with complete and valid actigraphy (n = 37) and sleep diaries were used to calculate sleep onset latency and sleep duration.

Primary outcome: Sleep Duration

Time frame: 8-10 weeks. Mean (Standard Deviation). Unit: minutes

Measure	Placebo n = 37	10mg of Either Focalin XR or Adderall XR n = 37	20 mg of Either Focalin XR or Adderall XR n = 37	25/30mg of Either Focalin XR or Adderall XR n = 37	Adderall XR All Dose Levels n = 37	Focalin XR All Dose Levels n = 37
Value	459.6 (73.6)	446.7 (63.58)	432.17 (64.6)	425.5 (61.5)	438.82 (67.2)	443.2 (66.9)

Population analysed: participants with sufficient sleep actigraphy data for analysis (n=37)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo of Focalin XR	0 of 48 (0%)	16 of 48 (33.3%)	Not reported
10mg of Focalin XR	0 of 53 (0%)	23 of 53 (43.4%)	Not reported
20 mg of Focalin XR	1 of 47 (2.1%)	32 of 47 (68.1%)	Not reported
25/30mg of Focalin XR	0 of 47 (0%)	22 of 47 (46.8%)	Not reported
Placebo of Adderall XR	0 of 54 (0%)	23 of 54 (42.6%)	Not reported
10mg of Adderall XR	0 of 55 (0%)	35 of 55 (63.6%)	Not reported
20 mg of Adderall XR	0 of 52 (0%)	29 of 52 (55.8%)	Not reported
25/30mg of Adderall XR	0 of 51 (0%)	31 of 51 (60.8%)	Not reported

Limitations and caveats (from the sponsor): Due to early withdrawal or loss of contact during the study, the sample size for analysis was smaller. The dosing design of the study may have led to more adverse events than would occur in clinic.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9204677Kaufman 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.
Background: PubMed 16601646Charach 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.
Background: PubMed 12025432Schachar 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.
Background: PubMed 10103335Pelham 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.
Background: PubMed 14595084Stein 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.
Results publication: PubMed 22136094Stein 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.
Derived from this study: PubMed 25056567Santisteban 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark A Stein, PhD principal investigator

University of Illinois-Chicago; Hyperactivity, Attention and Learning Problems Clinic (HALP)

Elizabeth Charney, MD principal investigator

University of Illinois-Chicago, Hyperactivity, Attention, and Learning Problems Clinic (HALP)

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexmethylphenidate and Mixed Amphetamine Salts, ER in people with Attention Deficit Hyperactivity Disorder, run by Seattle Children's Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. (time frame: 8-10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00393042, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.