Study on the best treatment for the Delayed Sleep Phase Syndrome in adults with ADHD.

Phase 1

• Conditions: Delayed Sleep Phase Syndrome (DSPS) in adult patients with Attention-Deficit/Hyperctivity Disorder (ADHD); MedDRA version: 16.1Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 100000004873; MedDRA version: 16.1Level: PTClassification code 10012209Term: Delayed sleep phaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-000320-18-NL
• Lead Sponsor: Parnassia Bavo Groep - PsyQ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-25
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

- Age between 18-55 years old
- Diagnosis ADHD
- Diagnosis DSPS
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 51
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the best treatment of the Delayed Sleep Phase Syndrome in adults with ADHD.;Secondary Objective: The effect of the treatment on health, quality of life, ADHD symtoms, and apetite.;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.;Timepoint(s) of evaluation of this end point: At study end.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Improvement of the apetite profiles of hormones leptin and ghrelin<br>- Improvement of insulin resistence<br>- Improvement of biomarker profiles<br>- improvement of heart rate variability<br>- Improvement of blood pressure and weight<br>- Prolongiation of the sleep duration, shortening of the sleep onset delay and the advancement of the wake-up time (as measured by Actigraphy)<br>- Decrease of daytime sleepiness<br>- Improvement of quality of life<br>- Decrease of ADHD symptoms <br>- Decrease of preference for carbonhydrate-rich foods<br>- Treatment satisfaction;Timepoint(s) of evaluation of this end point: At study end.