Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393042
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2006-10-25
Brief Title:
Sleep and Tolerability Study Comparing the Effects of Adderall XR and Focalin XR
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Sleep and Tolerability of Extended Release Dexmethylphenidate vs Mixed Amphetamine Salts A Double Blind Placebo Controlled Study SAT STUDY
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 dysphoriaeuphoria Little is known about the relative effects of different stimulant formulations and dosages ie 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-04 | None | None | None |
| 2006-0423 | None | None | None |