Clinical trial NCT00000389: Treatment for Anxiety in Children
Official title: Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obsessive-Compulsive Disorder
Anxiety Disorders
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety
Keywords: Adolescence
Anxiety Disorders
Child
Female
Fluvoxamine
Human
Male
Serotonin Uptake Inhibitors
Anxiety Disorders -- *drug therapy
Fluvoxamine -- *therapeutic use
Serotonin Uptake Inhibitors -- *therapeutic use
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
First posted: 1999-11-03
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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 criteria: - Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Laurence Greenhill, MD
role: PRINCIPAL_INVESTIGATOR
name: Mark Riddle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group. N Engl J Med. 2001 Apr 26;344(17):1279-85. doi: 10.1056/NEJM200104263441703.
citation: Coyle JT. Drug treatment of anxiety disorders in children. N Engl J Med. 2001 Apr 26;344(17):1326-7. doi: 10.1056/NEJM200104263441711. No abstract available.