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Treatment of Youth With ADHD and Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00012584
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : June 24, 2009
Information provided by:
National Institute of Mental Health (NIMH)

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Anxiety, Separation Social Phobia Generalized Anxiety Disorder Drug: methylphenidate Drug: fluvoxamine Not Applicable

Detailed Description:

Many children and adolescents with mental disorders in the United States are treated with multiple psychotropic medications even though there is not much information on how well these medications work together or if they are safe to administer together. Many youth with ADHD have co-occurring (comorbid) disorders such as oppositional-defiant disorder, anxiety disorders, and mood disorders. There is much interest in the treatment of children and adolescents with comorbid ADHD and anxiety disorders because this is a common condition in clinical practice. When children with both anxiety and ADHD receive stimulant medication for ADHD, their anxiety may not improve. SSRI medications represent a reasonable addition to stimulant treatment, as they are considered effective for anxiety disorders based on controlled trials in adults and open trials in children. However, there are no data from controlled studies regarding the tolerability and dosing of the combination of stimulant treatment (including methylphenidate) and SSRIs in the treatment of children with comorbid ADHD and anxiety disorder.

In this study, children and adolescents will be evaluated for the presence of both ADHD and Anxiety Disorder. Approximately 120 children and adolescents with both disorders who meet all the study entry requirements (such as being otherwise medically healthy) will be enrolled. Children and adolescents who are not on a stable dose of a stimulant will first be treated openly with methylphenidate for 6 weeks. Those whose ADHD does not improve during this initial treatment period will not continue in the study but will be referred for further support in the community. Those who show improvement in both their ADHD and anxiety symptoms will stay on methylphenidate for an additional 8 weeks. Those who show improvement in ADHD but not anxiety will be asked to enter the double-blind phase of the study. In this phase, participants will be randomized (assigned by chance) to receive either fluvoxamine or placebo, in combination with stimulant/methylphenidate, for 8 weeks. Children or adolescents who enter the study on a stable dose of stimulant will move directly to the Double-Blind phase. Participants who are assigned to placebo and who do not show an improvement in anxiety after 8 weeks will be eligible for an additional 8 weeks of open treatment with the methylphenidate/stimulant and fluvoxamine combination. At the end of the trial, clinical care will be provided for up to an additional month until referral to an outside clinician can be arranged.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Treatment Study of Youth With Comorbid Attention Deficit Hyperactivity Disorder (ADHD) and Anxiety Disorders
Study Start Date : November 2000
Actual Primary Completion Date : May 2002
Actual Study Completion Date : May 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00012584

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United States, California
UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90095
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
United States, New York
New York University Child Study Center
New York, New York, United States, 10016
New York State Psychiatric Institute
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Additional Information:
Layout table for additonal information Identifier: NCT00012584    
Other Study ID Numbers: N01 MH12012
First Posted: March 16, 2001    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: June 2009
Additional relevant MeSH terms:
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Anxiety Disorders
Attention Deficit Disorder with Hyperactivity
Phobia, Social
Anxiety, Separation
Pathologic Processes
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Phobic Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors