An intervention with Methylphenidate, Melatonin or Light Therapy will lead to changes in visual functioning.
ID
Bron
Verkorte titel
Aandoening
Attention-deficit/hyperactivity disorder (ADHD); Sleep; Circadian disturbances; Eye functioning
Ondersteuning
Kenniscentrum ADHD bij volwassenen
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The change in Post-Illumination Pupil Response (PIPR).
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
An intervention with Methylphenidate, Melatonin or Light Therapy will lead to changes in visual functioning.
Onderzoeksopzet
The assessments will take place at baseline and immediately after the 3-week intervention period.
Onderzoeksproduct en/of interventie
A 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
Publiek
Denise Bijlenga
Den Haag 2593 HR
The Netherlands
+31-(0)88 357 3076
dbijlenga@sein.nl
Wetenschappelijk
Denise Bijlenga
Den Haag 2593 HR
The Netherlands
+31-(0)88 357 3076
dbijlenga@sein.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patient group and control group: Age 18 to 40 years old. Patient group: Diagnosis of ADHD.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patient group and control group: Severe psychiatric comorbidity; substance abuse; contraindication for the intervention. Control group: ADHD; use of stimulant medication.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiƫnten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4187 |
NTR-old | NTR4337 |
Ander register | UTN: U1111-1151-6270 : 2013-005017-12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |