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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 tests

Number 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

Page last updated: August 23, 2015

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