Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial
Official title:
Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD): a Biomarker to Predict Treatment Response
This study investigates whether a relationship exists between pre-treatment brain characteristics and treatment response in adults with Attention Deficit Hyperactivity Disorder (ADHD).
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.
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