Effects of a Single Dose of Amisulpride on Functional Brain Changes (NCT05347199) | Clinical Trial Compass
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 range18 Years – 45 Years
SexALL
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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-Ã…sberg 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.