An interventional study of methylphenidate and fluvoxamine in Attention Deficit Hyperactivity Disorder, Anxiety, Separation and Social Phobia, sponsored by National Institute of Mental Health (NIMH). Completed at 5 sites in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2009-06-24.
Sponsored by National Institute of Mental Health (NIMH) · Not applicable, Interventional, and Treatment
Among 17 studies in Attention Deficit Disorder with Hyperactivity by National Institute of Mental Health (NIMH) — 5 open to participants now, 5 under way, none of them phase 3. Attention Deficit Disorder with Hyperactivity · National Institute of Mental Health (NIMH).
Among the 17 studies in Attention Deficit Disorder with Hyperactivity by National Institute of Mental Health (NIMH), this one is the only one that started in 2000, is one of 3 with no phase, and was the 5th registered.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
Browse Attention Deficit Disorder with Hyperactivity studies →5 of the 17 studies in Attention Deficit Disorder with Hyperactivity by National Institute of Mental Health (NIMH) are open now, in 1 country. Recruiting first, the newest first:
National Institute of Mental Health (NIMH) · Sites in United States
National Institute of Mental Health (NIMH) · Sites in United States
National Institute of Mental Health (NIMH) · Sites in United States
National Institute of Mental Health (NIMH) · Sites in United States
National Institute of Mental Health (NIMH) · Sites in United States
By country, each count listing its studies:
Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.
This study: 6 Years to 17 Years · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2
First in 1985; this study’s year is marked. 1 started in 2000.
This study's enrollment of 120 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Median enrollment 103 across the 5 interventional studies, 259 across the 12 observational. Of the 11 that completed or were terminated, 1 (9%) have results posted.
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National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 17 studies in Attention Deficit Disorder with Hyperactivity by National Institute of Mental Health (NIMH), from their registry updates:
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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.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The record gives a start of Nov 2000, a primary completion of May 2002 and a completion of May 2002. 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.
This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity →
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