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Effects of Modafinil, Caffeine and Methylphenidate in Healthy Volunteers (MKM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02071615
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : April 17, 2014
Sponsor:
Collaborator:
The Volkswagen Foundation
Information provided by (Responsible Party):
Dimitris Repantis, Charite University, Berlin, Germany

Brief 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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Methylphenidate 20 mg tablet given once by mouth Drug: modafinil 200mg tablet given once by mouth Drug: caffein 200mg tablet given once by mouth Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : August 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: Methylphenidate and placebo
Placebo or Methylphenidate 20 mg tablet given once by mouth
Drug: Methylphenidate 20 mg tablet given once by mouth
3-arm, single-drug dosage comparison study
Other Name: Ritalin

Drug: placebo
Experimental: modafinil and placebo
placebo or modafinil 200mg tablet given once by mouth
Drug: modafinil 200mg tablet given once by mouth
3-arm, single-drug dosage comparison study
Other Name: Provigil

Drug: placebo
Experimental: caffein and placebo
placebo or caffein 200mg tablet given once by mouth
Drug: caffein 200mg tablet given once by mouth
3-arm, single-drug dosage comparison study
Other Name: Coffeinum

Drug: placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071615


Locations
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Germany
Department of Psychiatry and Psychotherapy, Charité - University
Berlin, Germany, 14050
Sponsors and Collaborators
Charite University, Berlin, Germany
The Volkswagen Foundation
Investigators
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Principal Investigator: Dimitris Repantis, MD Department of Psychiatry and Psychotherapy, Charité - University

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Responsible Party: Dimitris Repantis, Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02071615    
Other Study ID Numbers: 2012-003882-17
DRKS00005219 ( Registry Identifier: Deutsche Register Klinischer Studien (DRKS) )
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014
Keywords provided by Dimitris Repantis, Charite University, Berlin, Germany:
Brain Activity
Additional relevant MeSH terms:
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Caffeine
Methylphenidate
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers