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Investigating the best treatment for the Delayed Sleep Phase Syndrome in adults with Attention-Deficit/Hyperactivity Disorder and itís effect on health and appetite


- candidate number14900
- NTR NumberNTR3999
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mei-2013
- Secondary IDsNL39579.058.12  CCMO
- Public TitleInvestigating the best treatment for the Delayed Sleep Phase Syndrome in adults with Attention-Deficit/Hyperactivity Disorder and itís effect on health and appetite
- Scientific TitlePhase shift in ADHD of sleep and appetite
- ACRONYMFASE
- hypothesisThis study will investigate the best treatment of Delayed Sleep Phase Syndrome (melatonin, placebo or melatonin and light therapy), and will determine whether patients with ADHD and DSPS have blood values that may indicate susceptibility for chronic diseases like diabetes.

The results will give insight into the association between DSPS, ADHD, and chronic conditions such as diabetes, and may serve as a model for the increase in obesity and metabolic syndrome in the general population, in which sleep loss is common due to the extended use of artificial light.
- Healt Condition(s) or Problem(s) studiedADHD, Delayed Sleep Phase Syndrome (DSPS)
- Inclusion criteria- Age between 18 and 55 years old
- Diagnosis ADHD
- Diagnosis DSPS
- Exclusion criteria- Psychotic illness
- Untreated mood disorder
- Untreated anxiety disorder
- Alcohol intake > 2U/day, or for woman >15U/week, for men >21 U/week
- Use of cannabis or harddrugs within one month prior to study participation
- Suspected dementia, anamnestic disorder or other cognitive disorder
- Mental retardation
- Use of the following medication within one month prior to study participation: psychostimulants, melatonin, mirtazapin, sleep medication, antipsychotics, clonidin, benzodiazepins, bŤta-blockers
- Insufficient fluency of the Dutch language
- Evening or night shift work
- Travel over >2 time zones two weeks prior to study participation (because of possible jet lag)
- Pregnancy or breast feeding
- Having young children who may disturb night rest
- Type 2 diabetes mellitus
- Light therapy one month prior to study particatipation
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-mei-2013
- planned closingdate16-mei-2014
- Target number of participants51
- InterventionsPatients will be randomized for sleep education, plus:
(1) 0.5 mg of melatonin daily,
(2) 0.5 mg of placebo daily, or
(3) 0.5 mg of melatonin daily, plus 30 minutes of light therapy in the morning between 7 and 8 AM.
Each treatment takes three weeks; the Melatonin intake will be three hours before the patientís individually determined Dim-Light Melatonin Onset (DLMO), and will be advanced during the treatment period.
- Primary outcomeThe phase shift of the sleep/wake cycle as evaluated by the time of DLMO directly after treatment.
- Secondary outcomeImprovement of appetite hormones
Improvement of diabetic parameters
Improvement of biomarker profiles
Improvement of cardiovascular parameters
Improvement of sleep parameters
Improvement of quality of life
Decrease of ADHD symptoms
Decrease of intake of carbohydrate-rich food
Treatment satisfaction
- TimepointsAll outcomes will be measured at baseline, directly after treatment and three weeks after treatment.

Methods of measurement:
Improvement of appetite hormones - blood
Improvement of diabetic parameters -blood
Improvement of biomarker profiles -blood
Improvement of cardiovascular parameters Ė ECG/ Ambulant Blood Pressure Monitor
Improvement of sleep parameters -actigraphy
Improvement of quality of life -questionnaire
Decrease of ADHD symptoms - questionnaire
Decrease of intake of carbohydrate-rich food -questionnaire
Treatment satisfaction -questionnaire
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESM.D. Suzan Vogel
- CONTACT for SCIENTIFIC QUERIESPhD Denise Bijlenga
- Sponsor/Initiator Director PsyQ The Hague
- Funding
(Source(s) of Monetary or Material Support)
Nuts/Ohra, PsyQ Expertise Center Adult ADHD, PsyQ Research Fund
- Publications
- Brief summaryAbout 80% of adults with Attention-Deficit/Hyperactivity Disorder (ADHD) have chronic sleep-onset problems and the majority of them has a Delayed Sleep Phase Syndrome (DSPS). DSPS is characterized by chronic sleep dept, which has negative consequences for physical health and is associated on the long term with weight gain, obesity, diabetes, hypertension, metabolic syndrome, cardiovascular disease, and even cancer. This study investigates the best treatment of DSPS (melatonin, placebo or melatonin and light therapy), and will determine whether patients with ADHD and DSPS have suboptimal biomarkers of chronic diseases like diabetes. Fifty-one adults with ADHD and DSPS will be recruited from the PsyQ Outpatient clinics in the Netherlands.
- Main changes (audit trail)
- RECORD17-mei-2013 - 30-mei-2013


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