Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025779
Status:
COMPLETED
Last Update Posted:
2009-07-28
First Post:
2001-10-23
Brief Title:
Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders
Status:
COMPLETED
Status Verified Date:
2008-08
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:
This study will evaluate the efficacy and safety of methylphenidate for treating hyperactivity impulsiveness and distractibility in 60 children and adolescents with Pervasive Developmental Disorders PDD Methylphenidate Ritalinis approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder ADHD Data supporting its safety and effectiveness in treating ADHD symptoms in PDD are limited Children and adolescents who do not show a positive response to methylphenidate will be invited to participate in a pilot study of the non-stimulant medication guanfacine Tenex
Detailed Description:
The safety and efficacy of methylphenidate MPH in 60 children and adolescents with PDD and behavioral difficulties such as hyperactivity impulsiveness and distractibility will be evaluated in a multi-dose 4-week randomized crossover placebo-controlled study The MPH study has three parts a Test-Dose Period a Double-Blind trial and an 8-Week Extension Period open-label After a screening visit eligible children will start a 1-week Test-Dose Period During this week each child will be given the three MPH doses that are used in the Double-Blind trial to make sure there are no serious side effects If problems are encountered at the high dose level that dose will not be given in the Double-Blind phase The Double-Blind phase lasts 4 weeks and consists of three different MPH dose levels and a week of placebo Each treatmentdose is given for 1 week and neither the researcher nor the participants families will know whether the medication is placebo or MPH Children who do well during this phase will continue on the best dose of MPH determined during the Double-Blind phase for an additional eight weeks open-label
Those who do not show significant improvement during the Double-Blind phase do not tolerate MPH during the Test Dose Period or are not able to take MPH before beginning the study are offered open-label treatment with guanfacine for 8 weeks
Prior to randomization in the MPH trial OR entry into the open-label guanfacine trial there will be a medication-free period for children who are currently on medication The withdrawal will be conducted in clinically appropriate way depending on drug and duration of treatment to minimize withdrawal effects This period is to establish a drug-free baseline measurement and to minimize drug-drug interaction No participant will be withdrawn from a currently effective medication
Those who do not show significant improvement during the Double-Blind phase do not tolerate MPH during the Test Dose Period or are not able to take MPH before beginning the study are offered open-label treatment with guanfacine for 8 weeks
Prior to randomization in the MPH trial OR entry into the open-label guanfacine trial there will be a medication-free period for children who are currently on medication The withdrawal will be conducted in clinically appropriate way depending on drug and duration of treatment to minimize withdrawal effects This period is to establish a drug-free baseline measurement and to minimize drug-drug interaction No participant will be withdrawn from a currently effective medication
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 |
|---|---|---|---|
| DSIR CT | None | None | None |
| N01 MH80011 | None | None | None |
| N01 MH70010 | None | None | None |
| N01 MH70001 | None | None | None |