Effects of a Single Dose of Amisulpride on Functional Brain Changes

Simone Grimm127 enrolled

Overview

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).

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- and motivation-related processing and at rest. Measurement of functional brain changes will occur after a single dose of amisulpride or placebo in HV and patients with MDD. It is hypothesized that functional brain changes previously linked to reward- and motivation-related processing require dopaminergic signaling and are diminished in MDD compared to HV. In MDD, but not in HV, treatment with a single low dose (100 mg) amisulpride should increase brain activation associated with reward- and motivation-related processing. To test these hypotheses, we will implement a randomized, placebo-controlled, parallel- group design with 4 treatment arms (MDD/placebo, MDD/amisulpride, HV/placebo and HV/ amisulpride). All subjects will undergo MRI scanning sessions at Visit 3 and Visit 4. Treatment with amisulpride or matching placebo will occur 3.5 to 4 hours before the start of each scanning session. Time of treatment will be standardized across subjects. At Visit 3 and Visit 4, blood samples will be taken 30 minutes pre-dose, and 1 hour, 3.5 to 4 hours, and 4.5 to 5 hours after oral drug administration to determine target plasma levels of amisulpride. The study is composed of 4 outpatient visits: Screening, baseline and 2 scanning sessions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

127

Conditions

Major Depressive Disorder

Interventions

Amisulpride PillDRUG

Two single low doses amisulpride (100 mg); orally

PlaceboDRUG

two doses, orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Charité Research Organisation GmbH

Berlin, Germany

Outcomes

Primary Outcomes

BOLD fMRI parameter estimates

Blood oxygen level dependent (BOLD) fMRI parameter estimates (ß-weights within the GLM analysis) will be extracted from task-related regions of interest (average %BOLD signal change and 90th percentile thereof within ROIs) under the following task-specific contrasts: Monetary Incentive Delay (MID) task: Contrast of 'High-gain'vs. 'No-gain' condition during the task CUE period ROIs ventral striatum (including nucleus accumbens)

Time frame: during MID task at treatment day 1

Data from ClinicalTrials.gov

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