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    Summary
    EudraCT Number:2012-000320-18
    Sponsor's Protocol Code Number:FASE01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-000320-18
    A.3Full title of the trial
    Phase shift in adult ADHD of sleep and apetite.
    Faseverschuiving bij volwassenen met ADHD van Slaap en Eetlust (FASE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the best treatment for the Delayed Sleep Phase Syndrome in adults with ADHD.
    Een onderzoek naar de beste behandeling van de verlate slaapfase bij volwassenen met ADHD
    A.3.2Name or abbreviated title of the trial where available
    FASE
    FASE
    A.4.1Sponsor's protocol code numberFASE01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorParnassia Bavo Groep - PsyQ
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPsyQ Expertise Center Adult ADHD
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportFonds NutsOhra
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPsyQ Haaglanden
    B.5.2Functional name of contact pointDr. D. Bijlenga
    B.5.3 Address:
    B.5.3.1Street AddressCarel Reinierszkade 197
    B.5.3.2Town/ cityThe Hague
    B.5.3.3Post code2593 HR
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310883573076
    B.5.5Fax number+310883584205
    B.5.6E-maild.bijlenga@psyq.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMelatonin
    D.3.2Product code MEL
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMelatonin
    D.3.9.1CAS number 73-31-4
    D.3.9.3Other descriptive nameMELATONIN
    D.3.9.4EV Substance CodeSUB14496MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical 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.1.1.1Medical 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
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10064104
    E.1.2Term ADHD
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10012209
    E.1.2Term Delayed sleep phase
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary 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.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary 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.5.1.1Timepoint(s) of evaluation of this end point
    At study end.
    Aan het einde van het onderzoek.
    E.5.2Secondary 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.5.2.1Timepoint(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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Derde groep: Melatonine plus Licht Therapy (LT)
    Third group: Melatonin plus Light Therapy (LT)
    E.8.2.4Number of treatment arms in the trial3
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 51
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state51
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The best treatment will be implemented in our daily psychiatric practice.
    De beste behandeling zal in de dagelijkse psychiatrische praktijk worden toegepast.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Netherlands Institue of Neuroscience
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-02
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