geen aandoening not applicable
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. • The participant has a body mass index of 18.5-30 kg/m2, inclusive, at the medical screening. • The participant is aged 18 to 35 years, inclusive, at the time of informed consent. • The volunteer is healthy, i.e. absence of all exclusion criteria and had normal or corrected to normal static binocular acuity with or without correction. • The participant signs and dates a written informed consent form before the start of the experiment. • The participant has sufficient English language skills to read and understand all instructions and perform the tasks in this study
Exclusion criteria
Exclusion criteria: • The volunteer has an uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other ab-normality, which may impact the ability of the subject to participate or potentially confound the study results. • The volunteer has existing major psychiatric symptoms. • The participant has known hypersensitivity to any component of the formulation or methylphenidate or related compounds. • The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the first visit or is unwilling to agree to abstain from alcohol from 24 hours prior to each test day and/or drugs throughout the study. • The participant has been diagnosed with ADHD. • The participant has any sensory or motor deficits, which could reasonably be expected to affect test performance. • Other exclusion criteria are excessive drinking (>20 glasses of alcohol-containing beverages a week), pregnancy or lactation, use of medication other than oral contraceptives, use of recreational drugs from 2 weeks before until the end of the experiment, any condition in which gastrointestinal motility might carry any risk. • The participant has dyslexia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are measures of exam performance. In our case, this means the number of correct responses to the factual exam questions (i.e., memory) as well as the questions related to understanding. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will use a series of well-established memory paradigms to evaluate the level of cognitive enhancement. We will additionally test the effect of enhanced cognition on inducing a liberal response criterion. Therefore, in addition to the other paradigms used, we will include measures to assess false memory formation, and check whether MHP contributes to formation of such memories. The study parameters for the secondary objectives are behavioral data from the (false) memory paradigms. Additionally, we will include a working memory capacity task and survey questions measuring mood and alertness to exclude possible confounding effects of these factors. | — |
Countries
Netherlands