Major Depressive DisorderPhase 1NCT05347199
Effects of a Single Dose of Amisulpride on Functional Brain Changes
A Phase 1 study testing Amisulpride Pill in people with Major Depressive Disorder, run by Simone Grimm at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Amisulpride Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteGermany
- Study dates
- 17 May 2022to 25 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female patients with MDD; aged 18 to 45 years
- Montgomery-Åsberg Depression Rating Scale (MADRS) score > 7 and <26 at screening.
- Healthy
- aged 18 to 45 years
Who cannot join
- 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:
- Meeting diagnostic criteria for any major psychiatric disorder.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Single Dose of Amisulpride on Functional Brain Changes During Reward- and Motivation-related Processing
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).
Read the 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- 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
- Major Depressive Disorder
- Being tested
- Amisulpride Pill, Placebo
- Keywords
- Major Depressive Disorder, Amisulpride, Functional Brain Changes, BOLD responses
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amisulpride PillDrug
Two single low doses amisulpride (100 mg); orally
PlaceboDrug
two doses, orally
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers Placebo | Placebo comparator | placebo pill at two time points Receives: Drug: Placebo |
| Healthy Volunteers Amisulpride | Active comparator | amisulpride pill at two time points Receives: Drug: Amisulpride Pill |
| MDD Patients Placebo | Active comparator | placebo pill at two time points Receives: Drug: Placebo |
| MDD Patients Amisulpride | Experimental | amisulpride pill at two time points Receives: Drug: Amisulpride Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: during MID task at treatment day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start17 May 2022
- Primary completion18 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simone Grimm
- Sponsor type
- University, hospital or other
- Collaborators
- Charité Research Organisation GmbH, Boehringer Ingelheim
- Responsible party
- Sponsor-investigator, Simone Grimm, Medical School Berlin
- Investigators
- Christian Keicher, Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347199
- Sponsor's protocol ID
- MSB-C002
- Status last verified
- Nov 2023
- First submitted
- 12 Apr 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38012795
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Dose of Amisulpride on Functional Brain Changes During Reward- and Motivation-related Processing
- ClinicalTrials.gov ID
- NCT05347199
- Acronym / sponsor ID
- MSB-C002
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Amisulpride, Functional Brain Changes, BOLD responses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Simone GrimmUniversity, hospital or other
- Collaborators
- Charité Research Organisation GmbH, Boehringer Ingelheim
- Study start
- 17 May 2022 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers Placebo | Placebo comparator | Drug: Placeboplacebo pill at two time points |
| Healthy Volunteers Amisulpride | Active comparator | Drug: Amisulpride Pillamisulpride pill at two time points |
| MDD Patients Placebo | Active comparator | Drug: Placeboplacebo pill at two time points |
| MDD Patients Amisulpride | Experimental | Drug: Amisulpride Pillamisulpride pill at two time points |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female patients with MDD; aged 18 to 45 years
- Montgomery-Åsberg Depression Rating Scale (MADRS) score > 7 and <26 at screening.
- Healthy
- aged 18 to 45 years
Key exclusion criteria (9 listed)
- 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.
- Meeting diagnostic criteria for any major psychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amisulpride PillTwo single low doses amisulpride (100 mg); orally | Drug | Healthy Volunteers Amisulpride, MDD Patients Amisulpride |
| Placebotwo doses, orally | Drug | Healthy Volunteers Placebo, MDD Patients Placebo |
Primary outcome
BOLD fMRI parameter estimates
Time frame: during MID task at treatment day 1
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 38012795Carstens 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Keicher, Dr. med. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amisulpride Pill in people with Major Depressive Disorder, run by Simone Grimm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD fMRI parameter estimates (time frame: during MID task at treatment day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05347199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.