E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Delayed Sleep Phase Syndrome (DSPS) in adult patients with Attention-Deficit/Hyperctivity Disorder (ADHD) |
Verlate slaapfase syndroom bij volwassen patienten met ADHD |
|
E.1.1.1 | Medical condition in easily understood language |
A clinical diagnosis of a having a delayed sleep phase (i.e. having a sleep/wake rhythm of a 'nightowl') in adult patients who are clinically diagnosed with ADHD. |
Een klinische diagnose van een verlate slaapfase (het hebben van het slaap/waak ritme van een late avond/nachtpersoon) bij volwassen patienten met een klinische diagnose van ADHD |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064104 |
E.1.2 | Term | ADHD |
E.1.2 | System Organ Class | 100000004873 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012209 |
E.1.2 | Term | Delayed sleep phase |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the best treatment of the Delayed Sleep Phase Syndrome in adults with ADHD. |
De beste behandeling van het verlate slaapfase syndroom bij volwassenen met ADHD. |
|
E.2.2 | Secondary objectives of the trial |
The effect of the treatment on health, quality of life, ADHD symtoms, and apetite. |
Het effect van behandeling op gezondheid, kwaliteit van leven, ADHD symptomen en eetlust |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age between 18-55 years old
- Diagnosis ADHD
- Diagnosis DSPS |
- Leeftijd tussen 18 en 55 jaar
- Diagnose ADHD
- Diagnose verlate slaapfase syndroom |
|
E.4 | Principal exclusion criteria |
- Psychotic illness;
- Untreated mood disorder;
- Untreated anxiety disorder;
- Alcohol intake > 2 U/day, or for women >15 U/week, for men >21 U/week;
- Use of cannabis;
- Use of harddrugs;
- Suspected dementia, anamnestic disorder of other cognitive disorder (DSM-IV);
- Mental retardation;
- Use of the following medication within 1 month prior to study participation: psychostimulants, melatonin, mirtazapin, sleep medication, antipsychotics, clonidin, benzodiazepins, bèta-blockers;
- Insufficient fluency of the Dutch language;
- Evening or night shift work;
- Travel over > 2 time zones within 2 weeks prior to study participation (because of possible jet lag);
- Pregnancy or breast feeding;
- Having joung children who may disturb night rest; |
- Psychotische stoornis;
- Onbehandelde stemmingsstoornis;
- Onbehandelde angststoornis;
- Gebruik van meer dan 2 eenheden alcohol/dag, of voor vrouwen meer dan 15 eenheden per week, voor mannen 21 eenheden per week;
- Gebruik van cannabis;
- Gebruik van harddrugs;
- Verdenking op dementie, een anamnestische stoornis of andere cognitieve stoornis (DSM-IV);
- Zwakbegaafdheid;
- Gebruik van de volgende medicatie binnen 1 maand voor deelname: stimulantia, melatonine, mirtazapine, slaapmedicatie, antipsychotica, clonidine, benzodiazepines, bètablokkers;
- Onvoldoende beheersing van de Nederlandse taal;
- Werk in onregelmatige dienst (avond of nacht);
- Reis over > 2 tijdzones in de 2 weken voorafgaand aan het onderzoek, i.v.m. mogelijke jetlag;
- Zwangerschap of geven van borstvoeding;
- Zeer jonge kinderen hebben die mogelijk de nachtrust verstoren |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The phase advance of the time of DLMO (the moment that the natural melatonin production reaches the 3 pg/mL threshold in saliva) at Followup 1. |
De vervroeging van het tijdstip van DLMO (het moment dat de melatonineproductie 's avonds een niveau van 3 pg/ml in speeksel bereikt) op Nameting 1. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At study end. |
Aan het einde van het onderzoek. |
|
E.5.2 | Secondary end point(s) |
- Improvement of the apetite profiles of hormones leptin and ghrelin
- Improvement of insulin resistence
- Improvement of biomarker profiles
- improvement of heart rate variability
- Improvement of blood pressure and weight
- Prolongiation of the sleep duration, shortening of the sleep onset delay and the advancement of the wake-up time (as measured by Actigraphy)
- Decrease of daytime sleepiness
- Improvement of quality of life
- Decrease of ADHD symptoms
- Decrease of preference for carbonhydrate-rich foods
- Treatment satisfaction |
- Verbetering van profiel van eetlusthormonen leptine en ghreline
- Verbetering van de insulineresistentie
- Verbetering van de biomarker profielen
- Verbetering van hartslagvariabiliteit
- Verbetering van de bloeddruk en gewicht
- Verlenging van de slaapduur, verkorting van de inslaapduur en vervroeging van het tijdstip van wakker worden (zoals gemeten met actigrafie)
- Vermindering van slaperigheid en vermoeidheid overdag
- Verbetering van de kwaliteit van leven
- Vermindering van de ADHD symptomen
- Vermindering van voorkeur voor koolhydraatrijk voedsel
- Behandelsatisfactie |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At study end. |
Aan het einde van het onderzoek. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Derde groep: Melatonine plus Licht Therapy (LT) |
Third group: Melatonin plus Light Therapy (LT) |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Laate bezoek van de laatste proefpersoon in het onderzoek. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |