NCT00012584

Brief Summary

The purpose of this NIMH-sponsored pilot study is to collect information on the efficacy and safety of drug treatments for children and adolescents who suffer from both ADHD and anxiety disorders. Specifically, the study will examine the benefits of the stimulant medication both alone and in combination with fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) that has antianxiety effects. Young people aged 6 to 17 diagnosed with these co-occurring disorders may be eligible to participate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2000

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
Last Updated

June 24, 2009

Status Verified

June 1, 2009

Enrollment Period

1.5 years

First QC Date

March 14, 2001

Last Update Submit

June 23, 2009

Conditions

Attention Deficit Hyperactivity DisorderAnxiety, SeparationSocial PhobiaGeneralized Anxiety Disorder

Interventions

methylphenidateDRUG
fluvoxamineDRUG

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* ADHD diagnosis * DSM-IV diagnosis of anxiety * IQ greater than 70 * residence with primary caretaker for at least 6 months * ages 6-17 and attending school * no previous treatment failure to or intolerance of fluvoxamine or methylphenidate (unless currently taking another stimulant)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

UCLA Neuropsychiatric Institute

Los Angeles, California, 90095, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

New York University Child Study Center

New York, New York, 10016, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • 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.

    PMID: 11323729BACKGROUND

  • 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.

    PMID: 11320394BACKGROUND

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAnxiety, SeparationPhobia, SocialGeneralized Anxiety Disorder

Interventions

MethylphenidateFluvoxamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersAnxiety DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOximesHydroxylaminesAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Start

November 1, 2000

Primary Completion

May 1, 2002

Study Completion

May 1, 2002

Last Updated

June 24, 2009

Record last verified: 2009-06

Locations

US(5)