Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000389
Status:
COMPLETED
Last Update Posted:
2007-06-14
First Post:
1999-11-02
Brief Title:
Treatment for Anxiety in Children
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study
Status:
COMPLETED
Status Verified Date:
2005-11
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 see if it is effective to treat children with anxiety disorders with fluvoxamine
Fluvoxamine has been successfully used to treat obsessive-compulsive disorder OCD in adults and children Anxiety disorders other than OCD such as generalized anxiety disorder social phobia or separation anxiety are very common in youth and are not always responsive to behavioral therapies alone These disorders may respond to fluvoxamine
A child will be evaluated for 3 weeks before heshe is assigned randomly like tossing a coin to receive either fluvoxamine or an inactive placebo for 8 weeks After this double-blind phase neither the childparents nor the doctor know which treatment is being given the child will have the option of continuing treatment during a 4-month open-label extension period both the childparents and the doctor know which the child is receiving
A child may be eligible for this study if heshe
Is 6 to 17 years old and has been diagnosed with an anxiety disorder ie generalized anxiety disorder social phobia or separation anxiety
Fluvoxamine has been successfully used to treat obsessive-compulsive disorder OCD in adults and children Anxiety disorders other than OCD such as generalized anxiety disorder social phobia or separation anxiety are very common in youth and are not always responsive to behavioral therapies alone These disorders may respond to fluvoxamine
A child will be evaluated for 3 weeks before heshe is assigned randomly like tossing a coin to receive either fluvoxamine or an inactive placebo for 8 weeks After this double-blind phase neither the childparents nor the doctor know which treatment is being given the child will have the option of continuing treatment during a 4-month open-label extension period both the childparents and the doctor know which the child is receiving
A child may be eligible for this study if heshe
Is 6 to 17 years old and has been diagnosed with an anxiety disorder ie generalized anxiety disorder social phobia or separation anxiety
Detailed Description:
To evaluate fluvoxamine in the treatment of children and adolescents with anxiety disorders
Fluvoxamine is a serotonin reuptake inhibitor that is FDA-approved for the treatment of obsessive-compulsive disorder OCD in adults and children Anxiety disorders other than OCD are very common in youth and are not always responsive to psychosocial therapies Fluvoxamine is an alternative treatment
After a 3-week period of evaluation patients meeting study entry criteria are randomized to receive either fluvoxamine or placebo for 8 weeks After this double-blind phase patients can enter a 4-month open-label extension
Fluvoxamine is a serotonin reuptake inhibitor that is FDA-approved for the treatment of obsessive-compulsive disorder OCD in adults and children Anxiety disorders other than OCD are very common in youth and are not always responsive to psychosocial therapies Fluvoxamine is an alternative treatment
After a 3-week period of evaluation patients meeting study entry criteria are randomized to receive either fluvoxamine or placebo for 8 weeks After this double-blind phase patients can enter a 4-month open-label extension
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 MH60016 | None | None | None |