A Phase 3 interventional study of Fluvoxamine in Obsessive-Compulsive Disorder, Anxiety Disorders and Generalized Anxiety Disorder, sponsored by National Institute of Mental Health (NIMH). Completed. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2007-06-14.
Sponsored by National Institute of Mental Health (NIMH) · Phase 3, Interventional, and Treatment
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.
No study locations are listed for this record.
This study is completed, as verified in Nov 2005. You cannot join it, but the record below documents what was studied.
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National Institute of Mental Health (NIMH)