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Effects of a Single Dose of Amisulpride on Functional Brain Changes

NCT ID: NCT05347199

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-17

Study Completion Date

2023-09-25

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Healthy Volunteers Placebo

placebo pill at two time points

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

two doses, orally

Healthy Volunteers Amisulpride

amisulpride pill at two time points

Group Type ACTIVE_COMPARATOR

Amisulpride Pill

Intervention Type DRUG

Two single low doses amisulpride (100 mg); orally

MDD Patients Placebo

placebo pill at two time points

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

two doses, orally

MDD Patients Amisulpride

amisulpride pill at two time points

Group Type EXPERIMENTAL

Amisulpride Pill

Intervention Type DRUG

Two single low doses amisulpride (100 mg); orally

Interventions

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Amisulpride Pill

Two single low doses amisulpride (100 mg); orally

Intervention Type DRUG

Placebo

two doses, orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charité Research Organisation GmbH

OTHER

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Simone Grimm

OTHER

Sponsor Role lead

Responsible Party

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Simone Grimm

Prof. Dr. habil.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christian Keicher, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité Research Organisation GmbH

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 38012795 (View on PubMed)

Other Identifiers

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MSB-C002

Identifier Type: -

Identifier Source: org_study_id