NCT03411434

Added Value of the Oculomotor and Cognitive Examination in the Management of Patients With ADHD

Status unknown NA Last updated 26 January 2018

What this trial tests

NA trial testing Methylphenidate Oral Tablet in Attention Deficit Hyperactivity Disorder in 90 participants. Status unknown.

Timeline

17 February 2014

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Centre Hospitalier Rouffach
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	90
Start date	17 February 2014
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across France

Drugs / interventions tested

• Methylphenidate Oral Tablet

Conditions studied

• Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →

Sponsor

Centre Hospitalier Rouffach

Who can join

Adults 7 to 50, any sex, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

ADHD is a neurodevelopmental disorder characterized by symptoms of inattention and / or hyperactivity-impulsivity that affects nearly 6% of school-aged children and persists into adulthood. More and more studies are interested in biomarkers of this pathology. The oculomotricity, which allows to highlight deficits motor and attention present in ADHD, is used routinely in the expert centers. In general, the pharmacological treatment of ADHD is associated with a clinical response in approximately 70% of cases. Today, there is no review to predict the individual response to treatment.

Hypotheses The investigators hypothesize that a precise analysis of the oculomotor markers will allow to measure the improvement of the symptomatology of the ADHD disorder following the introduction of the psycho-stimulatory treatment. In other words, the investigators hypothesize that these markers could be a useful aid in patient follow-up by the clinician and allow early identification of responder and non-responder patients.

Primary objective The main objective of this study is to measure the added value of oculomotor examination in the follow-up of psycho-stimulant-treated ADHD patients.

Main Evaluation Criteria The primary endpoint is oculomotor performance. Parameters analyzed for each saccade are latency, amplitude, duration, average speed, direction.

Secondary Criteria Evaluation (s) Correlations will be established between oculomotor data and scores obtained at the clinical scales assessing ADHD symptoms of inattention and hyperactivity as well as cognitive performance. The data obtained before the introduction of the psycho-stimulant treatment (V0, baseline) will be compared with those obtained after acute administration of methylphenidate (10 mg orally,V1) and during the follow-up visit at 6 months (V2).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. First-Dose Methylphenidate-Induced Changes in the Anti-Saccade Task Performance and Outcome in Adults with Attention-Deficit/Hyperactivity Disorder.
   Duval F, Erb A, Mokrani MC, Weiss T, et al · · 2021 · cited 4× · PMID 36101656 · DOI 10.1176/appi.prcp.20210010