Looking into the eye of ADHD.

Looking into the eye of ADHD. Investigating the relationship between ADHD, the delayed circadian rhythm and the functioning of the eye. - Looking in the eye of ADHD.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005017-12-NL

Enrollment

150

Registered

2014-02-25

Start date

2014-03-31

Completion date

Unknown

Last updated

2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults with ADHD and suboptimal eye functioning. MedDRA version: 16.1 Level: LLT Classification code 10064104 Term: ADHD System Organ Class: 100000004873

Interventions

Trade Name: Ritalin Product Name: Ritalin Pharmaceutical Form: Tablet INN or Proposed INN: METHYLPHENIDATE CAS Number: 113-45-1 Concentration unit: mg milligram(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient group and control group: Age 18 to 40 years old. Patient group: Diagnosis of ADHD. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient group and control group: Severe psychiatric comorbidity; substance abuse; contraindication for the intervention. Control group: ADHD; use of stimulant medication.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this project is to investigate associations between visual system functioning, ADHD, and the circadian rhythm. We will also investigate the effects on the functioning of the visual system of commonly used treatments for ADHD and related disorders: methylphenidate, light therapy, and melatonin. In case we find visual system deficiencies that are specific to ADHD, the development of an objective diagnostic test for ADHD will come closer. List of objectives: - To determine the prevalence and type of visual system deficiencies in adults with ADHD and in healthy controls. - To study the relationship between visual system deficiencies, ADHD symptoms, circadian rhythm, and comorbid psychiatric disorders. - To evaluate the single-dose effect of methylphenidate, melatonin and bright light on the visual system functioning in adults with ADHD. - To evaluate the effect of a 3-week treatment with these agents on the visual system functioning in adults with ADHD. ;Secondary Objective: Not applicable.;Primary end point(s): The Post-Illumination Pupil Response (PIPR) is the primary outcome measure. In order to evaluate if the functioning of the ipRGCs is involved in ADHD and any reported oversensitivity to light, the pupillary reflex is used. In the pupillary reflex the pupil’s diameter is adjusted to light intensity, protecting the retina from damage and optimizing vision. The Post-Illumination Pupil Response (PIPR) after red and blue light, is a measureable parameter of the functioning of the ipRGC system, and therefore an interesting outcome measure in our study. The PIPR of each person is unique, with very high intra-individual test-retest consistency. Any change in the PIPR can thus be allocated to an intervention with high probability.;Timepoint(s) of evaluation of this end point: After each of the three phases of the study, this endpoint will be used as the primary endpoint.	—

Measure

Time frame

Main Objective: The aim of this project is to investigate associations between visual system functioning, ADHD, and the circadian rhythm. We will also investigate the effects on the functioning of the visual system of commonly used treatments for ADHD and related disorders: methylphenidate, light therapy, and melatonin. In case we find visual system deficiencies that are specific to ADHD, the development of an objective diagnostic test for ADHD will come closer. List of objectives: - To determine the prevalence and type of visual system deficiencies in adults with ADHD and in healthy controls. - To study the relationship between visual system deficiencies, ADHD symptoms, circadian rhythm, and comorbid psychiatric disorders. - To evaluate the single-dose effect of methylphenidate, melatonin and bright light on the visual system functioning in adults with ADHD. - To evaluate the effect of a 3-week treatment with these agents on the visual system functioning in adults with ADHD. ;Secondary Objective: Not applicable.;Primary end point(s): The Post-Illumination Pupil Response (PIPR) is the primary outcome measure. In order to evaluate if the functioning of the ipRGCs is involved in ADHD and any reported oversensitivity to light, the pupillary reflex is used. In the pupillary reflex the pupil’s diameter is adjusted to light intensity, protecting the retina from damage and optimizing vision. The Post-Illumination Pupil Response (PIPR) after red and blue light, is a measureable parameter of the functioning of the ipRGC system, and therefore an interesting outcome measure in our study. The PIPR of each person is unique, with very high intra-individual test-retest consistency. Any change in the PIPR can thus be allocated to an intervention with high probability.;Timepoint(s) of evaluation of this end point: After each of the three phases of the study, this endpoint will be used as the primary endpoint.

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Secondary

Measure	Time frame
Secondary end point(s): - A change in outomes on the refractive error test for myopia (nearsightedness), hyperopia (farsightedness), astigmatism (cylindrical error), presbyopia (focus difficulty), and strabismus (alignedness of the eyes); - A change in colour discrimination ability; - A change in oculomotor functioning; - A change in perimetry score (visual field); - A change in the self-reported oversensitivity to light. - A change in the self-reported ADHD symptoms on the ADHD Rating Scale (ADHD-RS); - A change in the performance on the QbTest, which measures ADHD symptoms objectively; - A change in Dim-Light Melatonin Onset (DLMO); - A change in chronotype as measured by the Munich Chronotype Questionnaire (MCTQ); - A change in chronotype as measured by the Morningness-Eveningness Questionnaire (MEQ); - A change in fatigue as measured by the Shortened Fatigue Questionnaire (SFQ); - A change on the Seasonal Pattern Assessment Questionnaire (SPAQ).;Timepoint(s) of evaluation of this end point: After each of the three phases of the study, the sesecondary endpoints will be evaluated.	—

Measure

Time frame

Secondary end point(s): - A change in outomes on the refractive error test for myopia (nearsightedness), hyperopia (farsightedness), astigmatism (cylindrical error), presbyopia (focus difficulty), and strabismus (alignedness of the eyes); - A change in colour discrimination ability; - A change in oculomotor functioning; - A change in perimetry score (visual field); - A change in the self-reported oversensitivity to light. - A change in the self-reported ADHD symptoms on the ADHD Rating Scale (ADHD-RS); - A change in the performance on the QbTest, which measures ADHD symptoms objectively; - A change in Dim-Light Melatonin Onset (DLMO); - A change in chronotype as measured by the Munich Chronotype Questionnaire (MCTQ); - A change in chronotype as measured by the Morningness-Eveningness Questionnaire (MEQ); - A change in fatigue as measured by the Shortened Fatigue Questionnaire (SFQ); - A change on the Seasonal Pattern Assessment Questionnaire (SPAQ).;Timepoint(s) of evaluation of this end point: After each of the three phases of the study, the sesecondary endpoints will be evaluated.

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Countries

Netherlands

Contacts

Public ContactDr. D. Bijlenga

PsyQ Haaglanden

d.bijlenga@psyq.nl+310883573076

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026