Healthy volunteers (mechanistic study evaluating the effect of a single oral dose of ropinirole 1 mg on metacognition and resting‑state functional brain connectivity. Product has MA and has been shown to be safe in humans)
Conditions
Brief summary
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
Detailed description
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).
Interventions
DRUGplacebo
DRUGRequip 1 mg compresse rivestite con film
Sponsors
Universita' Degli Studi Di Modena E Reggio Emilia
Eligibility
Sex/Gender
Male
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Italy
Outcome results
None listed