Effects of Modafinil, Caffeine and Methylphenidate in Healthy Volunteers

Not Applicable

Completed

• Conditions: Healthy
• Interventions: 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

• Registration Number: NCT02071615
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-02-15
• Study First Submitted QC: 2014-02-22
• Study First Posted: 2014-02-26
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
caffein and placebo	placebo	placebo or caffein 200mg tablet given once by mouth
Methylphenidate and placebo	Methylphenidate 20 mg tablet given once by mouth	Placebo or Methylphenidate 20 mg tablet given once by mouth
Methylphenidate and placebo	placebo	Placebo or Methylphenidate 20 mg tablet given once by mouth
modafinil and placebo	modafinil 200mg tablet given once by mouth	placebo or modafinil 200mg tablet given once by mouth
modafinil and placebo	placebo	placebo or modafinil 200mg tablet given once by mouth
caffein and placebo	caffein 200mg tablet given once by mouth	placebo or caffein 200mg tablet given once by mouth

Primary Outcome Measures

Name	Time	Method
Resting state parameters of functional magnetic resonance imaging (fMRI) as a measure of brain activity	1 hour	The resting state parameters that will be measured are regional homogeneity (ReHo) und amplitude of low frequency fluctuation (ALFF)

Secondary Outcome Measures

Name	Time	Method
Performance on cognitive tests	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.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	24 hours

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy, Charité - University; 🇩🇪 Berlin, Germany