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OpenTrials
Completed

NCT Number: NCT02071615

Effects of Modafinil, Caffeine and Methylphenidate in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy, Charité - University

Berlin, State of Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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 )

Treatment and study plan

Methylphenidate 20 mg tablet given once by mouth

Drug

3-arm, single-drug dosage comparison study

Other names: Ritalin

modafinil 200mg tablet given once by mouth

Drug

3-arm, single-drug dosage comparison study

Other names: Provigil

caffein 200mg tablet given once by mouth

Drug

3-arm, single-drug dosage comparison study

Other names: Coffeinum

Placebo

Drug

Primary outcomes

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

    Time frame: 1 hour

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

Secondary outcomes

  1. Performance on cognitive tests

    Time frame: 4 hours

    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.

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

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • The Volkswagen Foundation

Registry information

Official study title

Effects of Modafinil, Caffeine and Methylphenidate on Functional Brain Activity and Cognitive Performance in Healthy Volunteers: a Randomized, Placebo-controlled, Double-blind fMRI Study

Acronym: MKM

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2014
Registry last updated
Apr 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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