Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000381
Status:
COMPLETED
Last Update Posted:
2014-01-08
First Post:
1999-11-02
Brief Title:
Fluoxetine for Anxious Children
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
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 safe and effective to use fluoxetine to treat children and adolescents with Generalized Anxiety Disorder GAD
Anxiety disorders are one of the most common psychiatric disorders in children and adolescents and can cause disturbances in the childs school social and family lives Having an anxiety disorder puts a child at risk for depression and drug abuse and appears to continue into adulthood There is very little information on anxiety medications for children
Children will be assigned randomly like tossing a coin to receive either fluoxetine or an inactive placebo for 12 weeks Each child will be monitored for symptoms and side effects throughout the study Heshe will have blood tests at Weeks 4 8 and 12 to measure drug levels in the blood The study will last for 12 weeks
A child is eligible for this study if heshe
Is 8 to 17 years old and has anxiety disorder
A child will not be eligible for this study if heshe
Has current major depression panic disorder or obsessive-compulsive disorder or abuses alcohol or drugs
Anxiety disorders are one of the most common psychiatric disorders in children and adolescents and can cause disturbances in the childs school social and family lives Having an anxiety disorder puts a child at risk for depression and drug abuse and appears to continue into adulthood There is very little information on anxiety medications for children
Children will be assigned randomly like tossing a coin to receive either fluoxetine or an inactive placebo for 12 weeks Each child will be monitored for symptoms and side effects throughout the study Heshe will have blood tests at Weeks 4 8 and 12 to measure drug levels in the blood The study will last for 12 weeks
A child is eligible for this study if heshe
Is 8 to 17 years old and has anxiety disorder
A child will not be eligible for this study if heshe
Has current major depression panic disorder or obsessive-compulsive disorder or abuses alcohol or drugs
Detailed Description:
To evaluate the safety and efficacy of fluoxetine as a treatment for children and adolescents with Generalized Anxiety Disorder GAD
Anxiety disorders are among the most common childhood and adolescent psychiatric disorders and are often associated with academic social and family morbidity These disorders frequently increase the risk for developing other psychiatric disorders eg depression substance abuse aggregate in families and appear to continue into adulthood Except for Obsessive-Compulsive Disorder there are very few pharmacological treatment studies for childhood anxiety disorders Given the sparsity and methodological problems of previous anxiety pharmacological studies it is clear that further investigation of the use of pharmacological treatment of children and adolescents with these disorders is needed
Patients are randomized to receive either fixed-dose fluoxetine or placebo for 12 weeks Patients are assessed for psychiatric symptomatology functional status and side effects In addition to assess attainment of steady state and compliance with treatment plasma levels of fluoxetine and norfluoxetine are measured at 4 8 and 12 weeks To standardize the treatment protocol and to assure that both groups fluoxetine and placebo receive equivalent nonpharmacological treatment a manual is used Potential predictors of clinical response such as age sex duration and severity of anxiety school absenteeism sub-syndromal depressive symptoms family history of anxiety or mood disorders are explored
Anxiety disorders are among the most common childhood and adolescent psychiatric disorders and are often associated with academic social and family morbidity These disorders frequently increase the risk for developing other psychiatric disorders eg depression substance abuse aggregate in families and appear to continue into adulthood Except for Obsessive-Compulsive Disorder there are very few pharmacological treatment studies for childhood anxiety disorders Given the sparsity and methodological problems of previous anxiety pharmacological studies it is clear that further investigation of the use of pharmacological treatment of children and adolescents with these disorders is needed
Patients are randomized to receive either fixed-dose fluoxetine or placebo for 12 weeks Patients are assessed for psychiatric symptomatology functional status and side effects In addition to assess attainment of steady state and compliance with treatment plasma levels of fluoxetine and norfluoxetine are measured at 4 8 and 12 weeks To standardize the treatment protocol and to assure that both groups fluoxetine and placebo receive equivalent nonpharmacological treatment a manual is used Potential predictors of clinical response such as age sex duration and severity of anxiety school absenteeism sub-syndromal depressive symptoms family history of anxiety or mood disorders are explored
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 |
|---|---|---|---|
| R01MH053681 | NIH | None | None |
| DSIR | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH053681 |