Effects of a Single Dose of Amisulpride on Functional Brain Changes

NCT05347199 | Completed Phase 1

• 1 other identifier: MSB-C002
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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 patients with Major Depressive Disorder (MDD).

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Amisulpride; Functional Brain Changes; BOLD responses

Outcome Measures

Primary Outcomes (1)

• 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)

  during MID task at treatment day 1

Other Outcomes (13)

• Exploratory endpoint: average %BOLD signal change and 90th percentile thereof within ROIs during SID

  during SID task at treatment day 2

• Exploratory endpoint: average %BOLD signal change and 90th percentile thereof within ROIs during intstrumental learning task

  during instrumental learning task at treatment day 1

• Exploratory endpoint: average %BOLD signal change and 90th percentile thereof within ROIs during effort-based decision making task

  during effort-based decision making task at treatment day 2

Study Arms (4)

Healthy Volunteers Placebo

PLACEBO COMPARATOR

placebo pill at two time points

Drug: Placebo

Healthy Volunteers Amisulpride

ACTIVE COMPARATOR

amisulpride pill at two time points

Drug: Amisulpride Pill

MDD Patients Placebo

ACTIVE COMPARATOR

placebo pill at two time points

Drug: Placebo

MDD Patients Amisulpride

EXPERIMENTAL

amisulpride pill at two time points

Drug: Amisulpride Pill

Interventions

Amisulpride Pill DRUG

Two single low doses amisulpride (100 mg); orally

Healthy Volunteers Amisulpride; MDD Patients Amisulpride

Placebo DRUG

two doses, orally

Healthy Volunteers Placebo; MDD Patients Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients with MDD; aged 18 to 45 years
• Montgomery-Åsberg Depression Rating Scale (MADRS) score \> 7 and \<26 at screening.

You may not qualify if:

• 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:
• Healthy
• aged 18 to 45 years
• 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.

Sponsors & Collaborators

• Simone Grimm: lead
• Charité Research Organisation GmbH: collaborator
• Boehringer Ingelheim: collaborator

Study Sites (1)

Charité Research Organisation GmbH

Berlin, Germany

Location

Related Publications (1)

• Carstens L, Popp M, Keicher C, Hertrampf R, Weigner D, Meiering MS, Luippold G, Sussmuth SD, Beckmann CF, Wunder A, Grimm S. Effects of a single dose of amisulpride on functional brain changes during reward- and motivation-related processing using task-based fMRI in healthy subjects and patients with major depressive disorder - study protocol for a randomized clinical trial. Trials. 2023 Nov 27;24(1):761. doi: 10.1186/s13063-023-07788-x.

  PMID: 38012795 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Christian Keicher, Dr. med.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. habil.

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 26, 2022
• Study Start: May 17, 2022
• Primary Completion: September 18, 2023
• Study Completion: September 25, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)