HealthyMKMNCT02071615
Effects of Modafinil, Caffeine and Methylphenidate in Healthy Volunteers
A study testing Methylphenidate 20 mg tablet given once by mouth, modafinil 200mg tablet given once by mouth and caffein 200mg tablet given once by mouth in people with Healthy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Methylphenidate 20 mg tablet given once by mouth, modafinil 200mg tablet given once by mouth and caffein 200mg tablet given once by mouth
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men
- 18 - 35 years
- Written consent (according to Arzneimittelgesetz (AMG) § 40 (1) 3b)
- Good knowledge of German
- Right-handedness
Who cannot join
- 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
Show all 12Show fewer
- 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 )
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, Charité - University
Berlin, State of Berlin, 14050
About this study
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
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
- Being tested
- Methylphenidate 20 mg tablet given once by mouth, modafinil 200mg tablet given once by mouth, caffein 200mg tablet given once by mouth, placebo
- Keywords
- Brain Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate 20 mg tablet given once by mouthDrug
Also called Ritalin
3-arm, single-drug dosage comparison study
modafinil 200mg tablet given once by mouthDrug
Also called Provigil
3-arm, single-drug dosage comparison study
caffein 200mg tablet given once by mouthDrug
Also called Coffeinum
3-arm, single-drug dosage comparison study
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate and placebo | Experimental | Placebo or Methylphenidate 20 mg tablet given once by mouth Receives: Drug: Methylphenidate 20 mg tablet given once by mouth; Drug: placebo |
| modafinil and placebo | Experimental | placebo or modafinil 200mg tablet given once by mouth Receives: Drug: modafinil 200mg tablet given once by mouth; Drug: placebo |
| caffein and placebo | Experimental | placebo or caffein 200mg tablet given once by mouth Receives: Drug: caffein 200mg tablet given once by mouth; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 hour
Secondary outcomes (2)
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.
Measured: 4 hours
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- The Volkswagen Foundation
- Responsible party
- Principal investigator, Dimitris Repantis, Charite University, Berlin, Germany
- Investigators
- Dimitris Repantis, MD, Principal investigator, Department of Psychiatry and Psychotherapy, Charité - University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071615
- Sponsor's protocol ID
- 2012-003882-17
- Other IDs
- DRKS00005219
- Acronym
- MKM
- Status last verified
- Apr 2014
- First submitted
- 15 Feb 2014
- Last updated
- 17 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02071615
- Acronym / sponsor ID
- MKM / 2012-003882-17
- Conditions
- Healthy
- Keywords
- Brain Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- The Volkswagen Foundation
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate and placebo | Experimental | Drug: Methylphenidate 20 mg tablet given once by mouth, Drug: placeboPlacebo or Methylphenidate 20 mg tablet given once by mouth |
| modafinil and placebo | Experimental | Drug: modafinil 200mg tablet given once by mouth, Drug: placeboplacebo or modafinil 200mg tablet given once by mouth |
| caffein and placebo | Experimental | Drug: caffein 200mg tablet given once by mouth, Drug: placeboplacebo or caffein 200mg tablet given once by mouth |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men
- 18 - 35 years
- Written consent (according to Arzneimittelgesetz (AMG) § 40 (1) 3b)
- Good knowledge of German
- Right-handedness
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidate 20 mg tablet given once by mouthAlso: Ritalin3-arm, single-drug dosage comparison study | Drug | Methylphenidate and placebo |
| modafinil 200mg tablet given once by mouthAlso: Provigil3-arm, single-drug dosage comparison study | Drug | modafinil and placebo |
| caffein 200mg tablet given once by mouthAlso: Coffeinum3-arm, single-drug dosage comparison study | Drug | caffein and placebo |
| placebo | Drug | Methylphenidate and placebo, caffein and placebo, modafinil and placebo |
Primary outcome
Resting state parameters of functional magnetic resonance imaging (fMRI) as a measure of brain activity
Time frame: 1 hour
The resting state parameters that will be measured are regional homogeneity (ReHo) und amplitude of low frequency fluctuation (ALFF)
2 secondary outcomes
Performance on cognitive tests
Time frame: 4 hours
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitris Repantis, MD principal investigator
Department of Psychiatry and Psychotherapy, Charité - University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylphenidate 20 mg tablet given once by mouth, modafinil 200mg tablet given once by mouth and caffein 200mg tablet given once by mouth in people with Healthy, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting state parameters of functional magnetic resonance imaging (fMRI) as a measure of brain activity (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.