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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00005219 | Registry Identifier | Deutsche Register Klinischer Studien (DRKS) |
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| Name | Class |
|---|---|
| The Volkswagen Foundation | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate and placebo | Experimental | Placebo or Methylphenidate 20 mg tablet given once by mouth |
|
| modafinil and placebo | Experimental | placebo or modafinil 200mg tablet given once by mouth |
|
| caffein and placebo | Experimental | placebo or caffein 200mg tablet given once by mouth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate 20 mg tablet given once by mouth | Drug | 3-arm, single-drug dosage comparison study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 hours |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitris Repantis, MD | Department of Psychiatry and Psychotherapy, Charité - University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy, Charité - University | Berlin | State of Berlin | 14050 | Germany |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 10, 2022 | |
| Reset | Jul 6, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 10, 2022 | Jul 6, 2023 |
| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D000077408 | Modafinil |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| modafinil 200mg tablet given once by mouth | Drug | 3-arm, single-drug dosage comparison study |
|
|
| caffein 200mg tablet given once by mouth | Drug | 3-arm, single-drug dosage comparison study |
|
|
| placebo | Drug |
|
| 24 hours |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |