Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study
Fluvoxamine
Mental Disorders+5
+ Phobic Disorders
+ Neurodevelopmental Disorders
Treatment Study
Summary
Study start date: October 1, 1996
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 6 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
- Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.