Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study investigates whether a relationship exists between pre-treatment brain
      characteristics and treatment response in adults with Attention Deficit Hyperactivity
      Disorder (ADHD).
    

Detailed description: 
      There is a pressing need in psychiatry to offer more individualised treatments, and to
      improve outcomes from clinical trials. This 'individualised medicine' approach requires the
      development of biomarkers of treatment response.

      60 adults with ADHD are recruited from the Adult ADHD Clinic at the Maudsley Hospital,
      London, United Kingdom.

      The study is developed over three sessions, two at baseline (DAY 1 and DAY 2) and one after
      two months of treatment (follow-up).

      The first two sessions are conceived as a single-blind non-randomised placebo-controlled
      cross-over experiment. The first 30 participants enrolled in the study receive a placebo
      tablet (ascorbic acid 50 mgs) on DAY 1 before the behavioural assessment and magnetic
      resonance imaging (MRI) scan. The behavioural assessment and the functional MRI measurements
      are repeated two days after (DAY 2), under a clinically effective dose (20 mgs) of
      short-acting methylphenidate (MPH).

      The order of the tablets is reverted for the remaining 30 participants to balance any
      potential expectation and practice effect between the two conditions. Placebo and medication
      are over-encapsulated with the same red opaque capsules by the pharmacy team. Also, the
      protocol followed during the two sessions is absolutely identical in respect of timing and
      tests administered in order to keep the participants blind to the drug condition (medication
      or placebo).

      After the scanning sessions, all the participants receive the same prescription of a
      long-acting formulation of MPH, according to the clinical guidelines adopted by the Maudsley
      Hospital. Treatment response is evaluated clinically and behaviourally after 2 months of
      treatment (follow-up). Pre-treatment brain characteristics are tested as potential predictors
      (biomarkers) of treatment response.
    

Intervention name(s): MPH
Intervention type(s): Drug
Intervention description(s): Participants undergo behavioural tests and brain scanning twice, once under placebo and once under an acute dose of MPH, before starting long-term treatment with a long-acting formulation of MPH used routinely at the Adult ADHD Clinic.
Other intervention name(s): Methylphenidate
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: 30 participants with Attention Deficit Hyperactivity Disorder (ADHD) undergo behavioural tests and brain scanning twice, once under placebo and once under an acute dose of methylphenidate (MPH). The order of the tablets is inverted for the second half of the sample, thus the last 30 participants undergo behavioural tests and brain scanning twice, once under an acute dose of MPH and once under placebo. All 60 participants are then treated with a long-acting formulation of MPH used routinely at the Adult ADHD Clinic.
Masking: Single (Participant)
Primary purpose: Other
Keywords: longitudinal study; magnetic resonance imaging (MRI); brain connectivity; biomarker; treatment response; methylphenidate; stimulant medication