Effects of Modafinil, Caffeine and Methylphenidate in Healthy Volunteers
Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: 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 (Drug)
Phase: N/A
Status: Completed
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s): Dimitris Repantis, MD, Principal Investigator, Affiliation: Department of Psychiatry and Psychotherapy, Charité - University
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Resting state parameters of functional magnetic resonance imaging (fMRI) as a measure of brain activity
Secondary outcome: Performance on cognitive testsNumber of Participants with Adverse Events as a Measure of Safety and Tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Male.
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 )
Locations and Contacts
Department of Psychiatry and Psychotherapy, Charité - University, Berlin 14050, Germany
Additional Information
Starting date: August 2013
Last updated: April 16, 2014
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