Effects of a Single Dose of Amisulpride on Functional Brain Changes

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Simone Grimm
• Collaborators: Boehringer Ingelheim; Charité Research Organisation GmbH
• Treatments: Amisulpride

Criteria

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.