ClinicalTrials.gg
CompletedNCT00000389Updated Jun 14, 2007

Treatment for Anxiety in Children

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

Phase
Phase 3
Study type
Interventional
Ages
6 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Obsessive-Compulsive Disorder by National Institute of Mental Health (NIMH) — 2 open to participants now, 2 under way, none of them phase 3. Obsessive-Compulsive Disorder · National Institute of Mental Health (NIMH).

Started
1996
with 1 other
Phase 3
3 of 16
none open now
Registered
1st of 16
by date

Among the 16 studies in Obsessive-Compulsive Disorder by National Institute of Mental Health (NIMH), this one is one of 2 that started in 1996, is one of 3 in phase 3, and was the 1st registered.

Obsessive-Compulsive Disorder

635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.

Browse Obsessive-Compulsive Disorder studies →

Open to participants now

2 of the 16 studies in Obsessive-Compulsive Disorder by National Institute of Mental Health (NIMH) are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 120 Obsessive-Compulsive Disorder studies recruiting now, 31 (26%) set no upper age limit and 81 (68%) stop at 75 or younger; 28 take children under 18; 18 take healthy volunteers.

This study: 6 Years to 17 Years · all sexes · no healthy volunteers.

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02

Study 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).

Read the 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Masking
Double

Interventions

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 11323729 ↗
  • 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. PubMed 11320394 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 1996 and a completion of Nov 1999. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 1999
First posted
Nov 3, 1999
Start
Oct 1996
Completion
Nov 1999
Last update
Jun 14, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Jun 14, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00000389
First posted
Nov 3, 1999
Start date
Oct 1996
Completion
Nov 1999
Last update
Jun 14, 2007

Study contacts

Laurence Greenhill, MD
principal investigator
Mark Riddle, MD
principal investigator
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Studies of the drug tested here: Fluvoxamine

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