Clinical Trial Results:
Phase shift in adult ADHD of sleep and apetite.
Summary
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EudraCT number |
2012-000320-18 |
Trial protocol |
NL |
Global end of trial date |
02 Jul 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jul 2021
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First version publication date |
29 Jul 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
FASE01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Dutch Trail Register: #NTR3831 | ||
Sponsors
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Sponsor organisation name |
Parnassia Bavo Groep
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Sponsor organisation address |
Denemarkenlaan 2, Zoetermeer, Netherlands, 2711 EL
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Public contact |
Dr. D. Bijlenga, PsyQ Haaglanden, +31 0883573076, d.bijlenga@psyq.nl
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Scientific contact |
Dr. D. Bijlenga, PsyQ Haaglanden, +31 0883573076, d.bijlenga@psyq.nl
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Oct 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Jul 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Jul 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To investigate the best treatment of the Delayed Sleep Phase Syndrome in adults with ADHD.
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Protection of trial subjects |
In case that disadvantages participation in the current trail outweigh the advantages, the ethical committee will be informed. The study will be suspended pending further review by the reviewing etical committee, unless this suspension could harm the health of the participants.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 51
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Worldwide total number of subjects |
51
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EEA total number of subjects |
51
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
51
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited from June 2013 to August 2016 and from April 2018 to June 2019 and followed up for 7 weeks after baseline. Participants were recruited from a outpatient clinic of PsyQ Adult ADHD. | ||||||||||||||||||||
Pre-assignment
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Screening details |
Inclusion: age between 18 and 55 y; fluency in the Dutch language; clinical diagnosis of both ADHD and DSPS. Exclusion: severe psychiatric disorders that need immediate treatment, neurological disorders, neurodegenerative diseases, mental retardation, shiftwork or BLT within the last month, prenancy. | ||||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||
Roles blinded |
Subject, Investigator, Carer, Assessor | ||||||||||||||||||||
Blinding implementation details |
Participants were randomly assigned, following simple randomization procedures (computer-generated randomization numbers)
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Melatonin | ||||||||||||||||||||
Arm description |
0.5 mg/d melatonin | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Melatonin
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Investigational medicinal product code |
73-31-4
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
1mg per day
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Arm title
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Placebo | ||||||||||||||||||||
Arm description |
Placebo | ||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
1 tablet a day
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Arm title
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Melatonin + BLT | ||||||||||||||||||||
Arm description |
Melatonin + Bright Light Therapy | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Melatonin
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Investigational medicinal product code |
73-31-4
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
0.5 mg per day
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Two participants dropped out prior to the baseline measurement because they were not willing or able to fullfill the study demands |
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Baseline characteristics reporting groups
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Reporting group title |
Melatonin
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Reporting group description |
0.5 mg/d melatonin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Melatonin + BLT
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Reporting group description |
Melatonin + Bright Light Therapy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Melatonin
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Reporting group description |
0.5 mg/d melatonin | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo | ||
Reporting group title |
Melatonin + BLT
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Reporting group description |
Melatonin + Bright Light Therapy |
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End point title |
DLMO | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The primary outcome, DLMO, was assessed at baseline (T0), the day after the 3-week treatment period (T1), and 2 weeks after the end of treatment (T2).
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Statistical analysis title |
Main effects | ||||||||||||||||
Statistical analysis description |
The effects of the three interventions on DLMO and ADHD-RS scores were compared using linear mixed models with T0 as reference, and corrected for baseline values of the outcomes.
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Comparison groups |
Placebo v Melatonin v Melatonin + BLT
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
- | ||||||||||||||||
upper limit |
- |
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End point title |
ADHD symptoms | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
The secondary outcome, ADHD symptoms, were assessed at baseline (T0),
the day after the 3-week treatment period (T1), and 2 weeks after the end of treatment (T2).
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
within 15 days after the event happened.
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
ToetsingOnline | ||
Dictionary version |
x
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events happened over the course of the study. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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04 Feb 2014 |
Venapunction or finger prick is added as alternative to a venflon for the blood sampling. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported | |||||||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/33121289 |