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Last Update Posted: 2007-06-14
Recruiting has ended
All Genders accepted | 6 Years-17 Years |
Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Treatment for Anxiety in Children
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 he/she 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 child/parents 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 child/parents and the doctor know which the child is receiving).
A child may be eligible for this study if he/she:
Is 6 to 17 years old and has been diagnosed with an anxiety disorder (i.e., generalized anxiety disorder, social phobia, or separation anxiety).
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.
Eligibility
Relevant conditions:
Obsessive-Compulsive Disorder
Anxiety Disorders
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
Inclusion criteria
locations
Data sourced from ClinicalTrials.gov