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van CCT (UK)

van CCT (UK)

Looking into the eye of ADHD.

- candidate number15941
- NTR NumberNTR4337
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-dec-2013
- Secondary IDs2013-005017-12 UTN: U1111-1151-6270
- Public TitleLooking into the eye of ADHD.
- Scientific TitleLooking into the eye of ADHD. Investigating the relationship between ADHD, the delayed circadian rhythm and the functioning of the eye.
- hypothesisAn intervention with Methylphenidate, Melatonin or Light Therapy will lead to changes in visual functioning.
- Healt Condition(s) or Problem(s) studiedADHD, Sleep habits, Circadian rhythm, Eye movements
- Inclusion criteriaPatient group and control group: Age 18 to 40 years old. Patient group: Diagnosis of ADHD.
- Exclusion criteriaPatient group and control group: Severe psychiatric comorbidity; substance abuse; contraindication for the intervention. Control group: ADHD; use of stimulant medication.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2015
- planned closingdate1-aug-2017
- Target number of participants60
- InterventionsA 3-week intervention of one of the following:

1A) Methylphenidate, 3 x 20 mg/day
1B) Placebo, 3 x 20mg/day

2A) Light Therapy, 30 minutes/day
2B) Waiting list

3A) Mel, 3 mg/day
3B) Placebo, 3 mg/day
- Primary outcomeThe change in Post-Illumination Pupil Response (PIPR).
- Secondary outcome- A change in 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 Multidimensional Assessment of Fatigue (MAF);
- A change on the Seasonal Pattern Assessment Questionnaire (SPAQ).
- TimepointsThe assessments will take place at baseline and immediately after the 3-week intervention period.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator PSYQ Haaglanden
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summaryThe study design consists of three phases, (1) exploring eye functioning in ADHD and healthy controls, (2) an explorative single-dose intervention of treatments commonly used in adults with ADHD on eye functioning, and (3) an effect evaluation of a 3-week treatment period of these commonly used treatments on eye functioning. This trial registration number only incorporates phase 3 of the project.

In Phase 3, ADHD patients that have participated in Phase 1 will be randomized for any of the interventions or for a placebo condition (as a control condition for Mph and Mel) or for a waiting list group (as a control condition for LT). Participants that have already participated in Phase 2, with major substance abuse, or any contra-indication for the interventions will be excluded. Each group will have n=10 participants per group, or, if the Phase 2 results indicate so, larger groups will be determined. All conditions and medication intake schedules are designed according usual treatment regimes:

1A) Mph, 3 x 20 mg/day at 8 AM, 12 PM and 4 PM during 3 weeks, n=10
1B) Placebo, 3 x 20mg/day at 8 AM, 12 PM and 4 PM during 3 weeks, n=10
2A) LT, 30 minutes/day in the morning during 3 weeks, n=10
2B) Waiting list during 3 weeks, n=10
3A) Mel, 3 mg/day in the evening 1 h before desired bedtime during 3 weeks, n=10
3B) Placebo, 3 mg/day in the evening 1 h before desired bedtime during 3 weeks, n=10

At baseline and ffter the 3-week intervention period, an eye functioning assessment battery will be assessed. The intra-individual change of the outcomes between the baseline and the Phase 3 measurements will be compared between the Mph and the placebo group, between the LT and waiting list group, and between the Mel and Placebo group. The correlation between the PIPR or any other eye functioning measure and the effect of the intervention on ADHD symptoms or circadian rhythm will be investigated. Any comorbidity, self-reported oversensitivity to light, and minor substance abuse will be analyzed as covariates in regression models when evaluating the effect of the interventions on the eye functioning improvement.
- Main changes (audit trail)
- RECORD24-dec-2013 - 10-jan-2014

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