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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00000389 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive-Compulsive Disorder Anxiety Disorders Generalized Anxiety Disorder Social Phobia Separation Anxiety |
Drug: Fluvoxamine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Placebo Control |
| Official Title: | Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study |
| Study Start Date: | October 1996 |
| Estimated Study Completion Date: | November 1999 |
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| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.
Contacts and Locations More Information
| Study ID Numbers: | N01 MH60005, N01 MH60016, DSIR CT |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00000389 History of Changes |
| Health Authority: | United States: Federal Government |
|
Adolescence Anxiety Disorders Child Female Fluvoxamine Human |
Male Serotonin Uptake Inhibitors Anxiety Disorders -- *drug therapy Fluvoxamine -- *therapeutic use Serotonin Uptake Inhibitors -- *therapeutic use |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Fluvoxamine Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Phobic Disorders Serotonin Uptake Inhibitors Pharmacologic Actions |
Serotonin Agents Pathologic Processes Anxiety Disorders Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Anti-Anxiety Agents Anxiety, Separation Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents Obsessive-Compulsive Disorder |
