Novelty learning and reward processing Memory and reward processing
Conditions
Interventions
In this study, you will receive four drugs at different times. This is called a 4-way crossover study, which means that you will receive each drug once, in random order, with periods (called washout p
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Signed informed consent prior to any study-mandated procedure. Healthy male or female participants, 18 to 40 years of age, inclusive at screening. Participant has a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening, and with a minimum weight of 50 kg. A self-reported normal or corrected vision. All women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 60 days after their last dose of study treatment.
Exclusion criteria
Exclusion criteria: Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the participant in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy participants. History of breast cancer, pheochromocytoma, hyperprolactinemia, or prolactin-dependent tumours such as pituitary prolactinomas or breast cancer. History of convulsions (other than benign febrile convulsions of childhood), including epilepsy, or personal history of significant cerebral trauma or central nervous system infections (e.g., meningitis), or any history or current evidence of movement disorders (e.g., extrapyramidal symptoms including tremor, rigidity, hypokinesia, akathisia or dyskinesia). Current diagnosis, personal history, or family history (in first degree; in second-degree relatives only when considered clinically significant in the opinion of the investigator) of a clinically significant psychiatric disorder, including substance use disorder (including psychostimulants such as methylphenidate, atomoxetine and/or (dex)amphetamine) or suicidality, at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the effects of single oral doses of amisulpride and modafinil on novelty-induced memory performance in healthy volunteersAssess the effects of single oral doses of amisulpride and modafinil on reward valuation and reward sensitivity using the GET in healthy volunteers | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the effects of single oral doses of amisulpride and modafinil on human spatial exploration in healthy volunteers.Explore the neural activity linked to memory performance induced by spatial novelty using electro encephalography (EEG) measurements during the novelty and memory tasks in healthy volunteers.Explore the effects induced by spatial novelty on sense of presence experienced in a virtual environment (VE) in healthy volunteers.Assess the broader PD effects of single oral doses of amisulpride and modafinil in healthy volunteers.Assess the effects of single oral doses of amisulpride and modafinil on reward learning using the SBT in healthy volunteersFurther explore the plasma PK profile of single oral doses of amisulpride and modafinil in plasma of healthy volunteers | — |
Countries
Netherlands
Contacts
Public ContactG.J. Jacobs
Centre for Human Drug Research
Outcome results
None listed