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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: placebo; 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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Methylphenidate and placebo; Placebo or Methylphenidate 20 mg tablet given once by mouth	Drug: placebo; Drug: Methylphenidate 20 mg tablet given once by mouth; 3-arm, single-drug dosage comparison study; Other Names: Ritalin
EXPERIMENTAL: modafinil and placebo; placebo or modafinil 200mg tablet given once by mouth	Drug: placebo; Drug: modafinil 200mg tablet given once by mouth; 3-arm, single-drug dosage comparison study; Other Names: Provigil
EXPERIMENTAL: caffein and placebo; placebo or caffein 200mg tablet given once by mouth	Drug: placebo; Drug: caffein 200mg tablet given once by mouth; 3-arm, single-drug dosage comparison study; Other Names: Coffeinum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		24 hours
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.	4 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: February 15, 2014
• First Submitted That Met QC Criteria: February 22, 2014
• First Posted (ESTIMATE): February 26, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 17, 2014
• Last Update Submitted That Met QC Criteria: April 16, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Brain Activity
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Dopamine Uptake Inhibitors; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Methylphenidate; Caffeine; Modafinil
• Other Study ID Numbers: 2012-003882-17; DRKS00005219 (REGISTRY: Deutsche Register Klinischer Studien (DRKS))