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

Phase shift in adult ADHD of sleep and apetite. - FASE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000320-18-NL

Enrollment

Registered

2012-09-25

Start date

2012-11-22

Completion date

Unknown

Last updated

2020-11-03

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

Conditions

Delayed Sleep Phase Syndrome (DSPS) in adult patients with Attention-Deficit/Hyperctivity Disorder (ADHD) MedDRA version: 16.1 Level: LLT Classification code 10064104 Term: ADHD System Organ Class: 100000004873 MedDRA version: 16.1 Level: PT Classification code 10012209 Term: Delayed sleep phase System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Melatonin Product Code: MEL Pharmaceutical Form: Tablet INN or Proposed INN: Melatonin CAS Number: 73-31-4 Other descriptive name: MELATONIN Concentration unit: mg milligram(s) Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

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

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;

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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;Timepoint(s) of evaluation of this end point: At study end.	—

Measure

Time frame

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;Timepoint(s) of evaluation of this end point: At study end.

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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