Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012584
Status:
COMPLETED
Last Update Posted:
2009-06-24
First Post:
2001-03-14
Brief Title:
Treatment of Youth With ADHD and Anxiety
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
A Treatment Study of Youth With Comorbid Attention Deficit Hyperactivity Disorder ADHD and Anxiety Disorders
Status:
COMPLETED
Status Verified Date:
2009-06
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 NIMH-sponsored pilot study is to collect information on the efficacy and safety of drug treatments for children and adolescents who suffer from both ADHD and anxiety disorders Specifically the study will examine the benefits of the stimulant medication both alone and in combination with fluvoxamine a selective serotonin reuptake inhibitor SSRI that has antianxiety effects Young people aged 6 to 17 diagnosed with these co-occurring disorders may be eligible to participate
Detailed Description:
Many children and adolescents with mental disorders in the United States are treated with multiple psychotropic medications even though there is not much information on how well these medications work together or if they are safe to administer together Many youth with ADHD have co-occurring comorbid disorders such as oppositional-defiant disorder anxiety disorders and mood disorders There is much interest in the treatment of children and adolescents with comorbid ADHD and anxiety disorders because this is a common condition in clinical practice When children with both anxiety and ADHD receive stimulant medication for ADHD their anxiety may not improve SSRI medications represent a reasonable addition to stimulant treatment as they are considered effective for anxiety disorders based on controlled trials in adults and open trials in children However there are no data from controlled studies regarding the tolerability and dosing of the combination of stimulant treatment including methylphenidate and SSRIs in the treatment of children with comorbid ADHD and anxiety disorder
In this study children and adolescents will be evaluated for the presence of both ADHD and Anxiety Disorder Approximately 120 children and adolescents with both disorders who meet all the study entry requirements such as being otherwise medically healthy will be enrolled Children and adolescents who are not on a stable dose of a stimulant will first be treated openly with methylphenidate for 6 weeks Those whose ADHD does not improve during this initial treatment period will not continue in the study but will be referred for further support in the community Those who show improvement in both their ADHD and anxiety symptoms will stay on methylphenidate for an additional 8 weeks Those who show improvement in ADHD but not anxiety will be asked to enter the double-blind phase of the study In this phase participants will be randomized assigned by chance to receive either fluvoxamine or placebo in combination with stimulantmethylphenidate for 8 weeks Children or adolescents who enter the study on a stable dose of stimulant will move directly to the Double-Blind phase Participants who are assigned to placebo and who do not show an improvement in anxiety after 8 weeks will be eligible for an additional 8 weeks of open treatment with the methylphenidatestimulant and fluvoxamine combination At the end of the trial clinical care will be provided for up to an additional month until referral to an outside clinician can be arranged
In this study children and adolescents will be evaluated for the presence of both ADHD and Anxiety Disorder Approximately 120 children and adolescents with both disorders who meet all the study entry requirements such as being otherwise medically healthy will be enrolled Children and adolescents who are not on a stable dose of a stimulant will first be treated openly with methylphenidate for 6 weeks Those whose ADHD does not improve during this initial treatment period will not continue in the study but will be referred for further support in the community Those who show improvement in both their ADHD and anxiety symptoms will stay on methylphenidate for an additional 8 weeks Those who show improvement in ADHD but not anxiety will be asked to enter the double-blind phase of the study In this phase participants will be randomized assigned by chance to receive either fluvoxamine or placebo in combination with stimulantmethylphenidate for 8 weeks Children or adolescents who enter the study on a stable dose of stimulant will move directly to the Double-Blind phase Participants who are assigned to placebo and who do not show an improvement in anxiety after 8 weeks will be eligible for an additional 8 weeks of open treatment with the methylphenidatestimulant and fluvoxamine combination At the end of the trial clinical care will be provided for up to an additional month until referral to an outside clinician can be arranged
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 |