Effects of Modafinil, Caffeine and Methylphenidate in Healthy Volunteers

NCT02071615 | Completed

• 2 other identifiers: 2012-003882-17DRKS00005219
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Brain Activity

Outcome Measures

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)

  1 hour

Secondary Outcomes (2)

• Performance on cognitive tests

  4 hours

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

  24 hours

Study Arms (3)

Methylphenidate and placebo

EXPERIMENTAL

Placebo or Methylphenidate 20 mg tablet given once by mouth

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

modafinil and placebo

EXPERIMENTAL

placebo or modafinil 200mg tablet given once by mouth

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

caffein and placebo

EXPERIMENTAL

placebo or caffein 200mg tablet given once by mouth

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

Interventions

Methylphenidate 20 mg tablet given once by mouth DRUG

3-arm, single-drug dosage comparison study

Also known as: Ritalin

Methylphenidate and placebo

modafinil 200mg tablet given once by mouth DRUG

3-arm, single-drug dosage comparison study

Also known as: Provigil

modafinil and placebo

caffein 200mg tablet given once by mouth DRUG

3-arm, single-drug dosage comparison study

Also known as: Coffeinum

caffein and placebo

placebo DRUG

Methylphenidate and placebo; caffein and placebo; modafinil and placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• The Volkswagen Foundation: collaborator

Study Sites (1)

Department of Psychiatry and Psychotherapy, Charité - University

Berlin, State of Berlin, 14050, Germany

Location

MeSH Terms

Interventions

Methylphenidate; Modafinil; Caffeine

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Xanthines; Alkaloids; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dimitris Repantis, MD

  Department of Psychiatry and Psychotherapy, Charité - University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: February 15, 2014
• First Posted: February 26, 2014
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

DE (1)