ROPINIROLE for Healthy volunteers

Inclusion criteria

• {"criterion_text":"- Male"}
• {"criterion_text":"- Nonsmoker"}
• {"criterion_text":"- Cognitively healthy (Mini-Mental State Examination, MMSE=30)"}
• {"criterion_text":"- Age 20-35"}
• {"criterion_text":"- Able to understand and write in Italian"}
• {"criterion_text":"- Years of Education > 13 years"}
• {"criterion_text":"- Participants are required to ensure no alcohol or any psychotropic substance intake for all the duration of the study"}
• {"criterion_text":"- Consent to refrain from driving until midnight in the day of the session"}
• {"criterion_text":"- Required to fast 3 hours before drug/placebo administration"}
• {"criterion_text":"- On no medical treatment"}

Exclusion criteria

• {"criterion_text":"- Known allergy to ropinirole and to eccipients"}
• {"criterion_text":"- Controindication to MRI (e.g. claustrophobia, metallic implants or foreign bodies, pacemaker)"}
• {"criterion_text":"- History of neurological or psychiatric conditions at screening visit or from past history"}
• {"criterion_text":"- Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular or oncologic disease, or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results"}
• {"criterion_text":"- Evidence of renal (creatinine clearance < 60 mL/min) or hepatic dysfunction (GOT/GPT > 31 U/L) on blood testing at screening or from past clinical history"}
• {"criterion_text":"- History of substance abuse"}
• {"criterion_text":"- On medical treatment at screening"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint will be the within-participant change in metacognitive efficiency (M-ratio; meta-d'/d') under ropinirole 1 mg versus placebo, estimated from confidence ratings on cognitive testing. It will be derived from trial-wise accuracy and confidence ratings on a modified version of the Rey Auditory-Verbal Learning Test, and computed using a signal-detection-theoretic framework, which separates metacognitive sensitivity from task performance","definition_or_measurement_approach":"Derived from trial-wise accuracy and confidence ratings on a modified Rey Auditory-Verbal Learning Test; computed using a signal-detection-theoretic framework (M-ratio; meta-d'/d') to separate metacognitive sensitivity from task performance."}

Secondary endpoints

• {"endpoint_text":"- Secondary endpoints will be pre-specified seed-to-seed connectivity measures from Resting-state fMRI (rs-fMRI) data specifically targeting the Default Mode Network (DMN) and Salience Network (SN).","definition_or_measurement_approach":"Pre-specified seed-to-seed connectivity measures computed from resting-state fMRI data targeting DMN and SN networks."}

Italy

Earliest CTIS Part Ii Submission Date

25-11-2025

Latest Decision Or Authorization Date

10-12-2025

Processing Time Days

15

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Universita' Degli Studi Di Modena E Reggio Emilia

Organisation Type

Educational Institution

Country Of Registered Address

Italy