Treatment of Youth With ADHD and Anxiety
Condition: Attention Deficit Hyperactivity Disorder; Anxiety, Separation; Social Phobia; Generalized Anxiety Disorder
MeSH terms: Hyperkinesis; Anxiety Disorders; Attention Deficit Disorder with Hyperactivity; Phobia, Social; Anxiety, Separation
Study type: Interventional

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.
    

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.
    

Intervention name(s): methylphenidate; fluvoxamine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluvoxamine; Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment