Clinical Trial Results:
Effects of modafinil, caffeine and methylphenidate on functional brain activity and cognitive performance in healthy subjects: a randomized, placebo-controlled, double-blind fMRI study.
Summary
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EudraCT number |
2012-003882-17 |
Trial protocol |
DE |
Global end of trial date |
31 Mar 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Apr 2022
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First version publication date |
03 Apr 2022
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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 |
MKM
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02071615 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Charité - Universitätsmedizin Berlin
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Sponsor organisation address |
Hindenburgdamm 30, Berlin, Germany, 12203
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Public contact |
Dr. Dimitris Repantis, Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charitè-Universitätsmedizin, CBF, dimitris.repantis@charite.de
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Scientific contact |
Dr. Dimitris Repantis, Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charitè-Universitätsmedizin, CBF, dimitris.repantis@charite.de
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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 |
31 Mar 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Mar 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Mar 2014
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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 |
Resting state parameters from functional magnetic resonance imaging (fMRI).
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Protection of trial subjects |
Safety: Blood pressure, heart rate, measures of subjective well-being (Visual Analogue Mood Scales, VAMS), adverse events (AE), serious adverse events (SAE), serious adverse reactions (SAR)
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 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 |
Germany: 48
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Worldwide total number of subjects |
48
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EEA total number of subjects |
48
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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) |
48
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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 |
The study was conducted at one study centers at Charité -Klinik für Psychiatrie und Psychotherapie- between August, 8th 2013 and March, 30 2014. | ||||||||||||
Pre-assignment
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Screening details |
right-handedness, healthy, male volunteers between 18-35th ages. Exclusion criteria: smokers or ex-smokers for less than 5 years, regular coffeine consumption> 4 cups per day, subjects with irregular circadian rhythm (eg shift workers), MR contraindications or other somatic illnesses or psychiatric disorders | ||||||||||||
Period 1
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Period 1 title |
overal 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 | ||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Methylphanidate + Placebo | ||||||||||||
Arm description |
Methylphenidate: single dose, 20 mg Methylphenidat Hexal®. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Methylphenidate
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Investigational medicinal product code |
19262-68-1
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Other name |
DEXMETHYLPHENIDATE HYDROCHLORIDE
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
subject received single dose 20mg Methylphenidate
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Arm title
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Modafinil + Placebo | ||||||||||||
Arm description |
Modafinil: single dose, 200 mg Vigil® | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Modafinil
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Investigational medicinal product code |
68693-11-8
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
subject received single dose 200mg Modafinil
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Arm title
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Coffeine + Placebo | ||||||||||||
Arm description |
Coffeine: single dose, 200 mg Coffeinum® | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Coffeine
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Investigational medicinal product code |
58-08-2
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Other name |
ANHYDROUS CAFFEINE
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
subject received single dose 200mg Coffeine
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Baseline characteristics reporting groups
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Reporting group title |
overal trial
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Reporting group description |
- | ||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Methylphanidate + Placebo
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Reporting group description |
Methylphenidate: single dose, 20 mg Methylphenidat Hexal®. | ||
Reporting group title |
Modafinil + Placebo
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Reporting group description |
Modafinil: single dose, 200 mg Vigil® | ||
Reporting group title |
Coffeine + Placebo
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Reporting group description |
Coffeine: single dose, 200 mg Coffeinum® |
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End point title |
functional connectivity (FC) | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
90 min
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Statistical analysis title |
functional connectivity | ||||||||||||||||
Comparison groups |
Methylphanidate + Placebo v Modafinil + Placebo v Coffeine + Placebo
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Number of subjects included in analysis |
48
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
P-value |
≤ 0.05 | ||||||||||||||||
Method |
General Linear Model | ||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Day of assessment
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
own system | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Methylphanidate + Placebo
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Reporting group description |
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Reporting group title |
Modafin.+Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Coffein+Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
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/33201262 |