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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00012584 |
Purpose
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 | Intervention |
|---|---|
|
Attention Deficit Hyperactivity Disorder Anxiety, Separation Social Phobia Generalized Anxiety Disorder |
Drug: methylphenidate Drug: fluvoxamine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Treatment Study of Youth With Comorbid Attention Deficit Hyperactivity Disorder (ADHD) and Anxiety Disorders |
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2000 |
| Study Completion Date: | May 2002 |
| Primary Completion Date: | May 2002 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations| 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 State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| New York University Child Study Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
More Information
| Study ID Numbers: | N01 MH12012, DSIR CT |
| Study First Received: | March 14, 2001 |
| Last Updated: | March 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00012584 History of Changes |
| Health Authority: | United States: Federal Government |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Fluvoxamine Psychotropic Drugs Methylphenidate Signs and Symptoms Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Hyperkinesis Antidepressive Agents, Second-Generation Antidepressive Agents |
Tranquilizing Agents Attention Deficit and Disruptive Behavior Disorders Central Nervous System Depressants Central Nervous System Stimulants Phobic Disorders Dyskinesias Serotonin Uptake Inhibitors Serotonin Anxiety Disorders Neurologic Manifestations Dopamine Agents Anti-Anxiety Agents Anxiety, Separation |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Fluvoxamine Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Methylphenidate Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis |
Antidepressive Agents, Second-Generation Antidepressive Agents Tranquilizing Agents Disease Nervous System Diseases Central Nervous System Depressants Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Phobic Disorders Serotonin Uptake Inhibitors Dyskinesias Pharmacologic Actions Serotonin Agents Anxiety Disorders Neurologic Manifestations |
