CompletedPhase 1

Effects of a Single Dose of Amisulpride on Functional Brain Changes

Germany127 participantsStarted 2022-05-17

Plain-language summary

This study is designed to investigate effects of a single dose of amisulpride on functional brain changes during reward- and motivation-related processing and at rest in healthy volunteers (HV) and in patients with Major Depressive Disorder (MDD).

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

MDD Patients: Inclusion: * Male and female patients with MDD; aged 18 to 45 years * Montgomery-Åsberg Depression Rating Scale (MADRS) score \> 7 and \<26 at screening. Exclusion: * Meeting diagnostic criteria for any major psychiatric disorder (other than MDD), as determined by DSM-5 at screening. * Having received prescribed medication (including antidepressants (AD)) within 14 days or fluoxetine within 90 days prior to Visit 3 (apart from the contraceptive pill). * Having received psychotherapy within 14 days prior to Visit 3. * Positive severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) test. Healthy Volunteers: Inclusion: * Healthy * aged 18 to 45 years Exclusion: * Meeting diagnostic criteria for any major psychiatric disorder. * A history of psychiatric or neurologic disorders. * Having received prescribed medication within 14 days prior to Visit 3 (apart from the contraceptive pill). * Positive SARS-CoV-2 test.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

BOLD fMRI parameter estimates

Timeframe: during MID task at treatment day 1

Trial details

NCT IDNCT05347199

SponsorSimone Grimm

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-18

View on ClinicalTrials.gov More Major Depressive Disorder trials

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.