Treatment for Anxiety in Children
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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 3 |
| Study Type: | Interventional |
| Study Design: | Masking: Double-Blind Primary Purpose: Treatment |
| 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
Publications:
| ClinicalTrials.gov Identifier: | NCT00000389 History of Changes |
| Other Study ID Numbers: | N01 MH60005, N01 MH60016, DSIR CT |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 13, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Fluvoxamine Fluvoxamine -- *therapeutic use Adolescence Anxiety Disorders Child Female |
Human Male Serotonin Uptake Inhibitors Anxiety Disorders -- *drug therapy Serotonin Uptake Inhibitors -- *therapeutic use |
Additional relevant MeSH terms:
|
Fluvoxamine Anxiety Disorders Anxiety, Separation Mental Disorders Obsessive-Compulsive Disorder Phobic Disorders Mental Disorders Diagnosed in Childhood Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 23, 2013