Status:
COMPLETED
Effects of a Single Dose of Amisulpride on Functional Brain Changes
Lead Sponsor:
Simone Grimm
Collaborating Sponsors:
Charité Research Organisation GmbH
Boehringer Ingelheim
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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...
Detailed Description
Double blind, placebo-controlled, randomized, single dose, parallel-group design The study is designed to investigate effects of a single dose of amisulpride on functional brain changes during reward-...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2023
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT05347199
Start Date
May 17 2022
End Date
September 25 2023
Last Update
November 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité Research Organisation GmbH
Berlin, Germany