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CompletedNCT02071615MKMUpdated Apr 17, 2014

Effects of Modafinil, Caffeine and Methylphenidate in Healthy Volunteers

An interventional study of Methylphenidate 20 mg tablet given once by mouth and modafinil 200mg tablet given once by mouth in Healthy, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-17.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study summary

In this study the investigators compare three stimulants to each other. The effects of these agents on cognitive performance (eg, attention and memory) and on the brain are being measured. The hypothesis is that stimulants will have a positive effect on cognitive performance.

Each study participant will receive once a placebo and once methylphenidate or modafinil or caffeine. Methylphenidate (also known as Ritalin ®) is a drug that is used in the treatment of attention deficit / hyperactivity disorder (ADHD) in children, adolescents and adults. Modafinil ( Vigil ®) is a drug used in the treatment of narcolepsy (sleeping sickness). In the study. These substances are given in the study only once and in the dosages in which is also used for the treatment of the above diseases. In the case of caffeine , the dosage corresponds to two cups of coffee.

02

Conditions studied

  • Healthy

Keywords

  • Brain Activity
03

In context

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Men
  • 18 - 35 years
  • Written consent (according to Arzneimittelgesetz (AMG) § 40 (1) 3b)
  • Good knowledge of German
  • Right-handedness

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity to the study medication
  • All contraindications to the study medication: arrhythmia, hyperthyroidism , glaucoma , pheochromocytoma , congestive heart failure , diabetes mellitus, known liver and kidney dysfunction, vascular disease , angina, haemodynamically significant congenital heart disease , cardiomyopathy , myocardial infarction, channelopathies, arterial hypertension , cerebrovascular diseases , such as cerebral aneurysm , vascular abnormalities , including vasculitis and stroke.
  • Participation in other clinical trials during or within one month prior to this clinical trial
  • Medical or psychological circumstances that may endanger the proper conduct of the trial
  • Existing serious somatic diseases, even if they are not covered by the contraindications according to product information
  • Existing psychiatric disorders and psychiatric disorders in prehistory
  • Smoker or ex-smoker for less than 5 years
  • Regular caffeine consumption > 4 cups per day
  • Subjects with irregular day -night rhythm (eg shift workers )
  • Unwillingness to the storage and disclosure of pseudonymous data as part of the clinical trial
  • Accommodation in an institution by court or administrative order (according to AMG § 40 (1) 4 )
  • MRI contraindications ( eg pacemakers , metallic or electronic implants , metallic splinters , tinnitus, surgical clips )
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Methylphenidate and placebo

    Placebo or Methylphenidate 20 mg tablet given once by mouth

    Drug: Methylphenidate 20 mg tablet given once by mouth · Drug: placebo

  • Experimental
    modafinil and placebo

    placebo or modafinil 200mg tablet given once by mouth

    Drug: modafinil 200mg tablet given once by mouth · Drug: placebo

  • Experimental
    caffein and placebo

    placebo or caffein 200mg tablet given once by mouth

    Drug: caffein 200mg tablet given once by mouth · Drug: placebo

Interventions

  • DrugMethylphenidate 20 mg tablet given once by mouth

    3-arm, single-drug dosage comparison study

    Also known as: Ritalin

  • Drugmodafinil 200mg tablet given once by mouth

    3-arm, single-drug dosage comparison study

    Also known as: Provigil

  • Drugcaffein 200mg tablet given once by mouth

    3-arm, single-drug dosage comparison study

    Also known as: Coffeinum

  • Drugplacebo
06

What researchers measure

Primary outcomes

  1. Resting state parameters of functional magnetic resonance imaging (fMRI) as a measure of brain activity

    The resting state parameters that will be measured are regional homogeneity (ReHo) und amplitude of low frequency fluctuation (ALFF)

    Time frame: 1 hour

Secondary outcomes

  1. Performance on cognitive tests

    A test battery covering several cognitive domaines is being used including: digit-span-Task, dual n-back, psychomotor vigilance task, reasoning task, memory task (free recall/ recognition), mental speed task.

    Time frame: 4 hours

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 24 hours

07

Study locations

1 site
  • Department of Psychiatry and Psychotherapy, Charité - University
    Berlin, 14050, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02071615
Lead sponsor
Charite University, Berlin, Germany
Collaborators
The Volkswagen Foundation
Responsible party
Dimitris Repantis (Dr. med., Charite University, Berlin, Germany) — Principal investigator
First posted
Feb 26, 2014
Start date
Aug 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Apr 17, 2014

Study contacts

Dimitris Repantis, MD
principal investigator · Department of Psychiatry and Psychotherapy, Charité - University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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