Depression - Major Depressive DisorderPhase 1NCT07490353
Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects
A Phase 1 study testing Psilocybin (Usona Institute), Risperidone 1 MG and MRI in people with Depression - Major Depressive Disorder and Anhedonia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The goal of this clinical trial is to systematically categorize potential prohedonic effects of psilocybin in patients with anhedonia in depression. The main questions it aims to answer are: Primary Objectives 1. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression - Major Depressive Disorder, Anhedonia
- What is being tested?
- Psilocybin (Usona Institute), Risperidone 1 MG and MRI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2025to 31 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants:
- General health based on medical history, physical examination, blood draw, and electrocardiogram
- Age 18 to 55 years
- Right-handedness (due to potential lateralization effects of left-handed subjects)
- Willingness and competence to sign the informed consent form
- Normal BMI weight range (18.5-24.9)
Show all 13Show fewer
- Specific to healthy subjects:
- Psychiatric health based on structured clinical interview for DSM-5 (SCID)
- No concomitant medication
- Specific to anhedonia patients:
- Major depressive episode (first or recurrent) based on structured clinical interview for DSM-5 (SCID) and ICD-10
- Fulfilling the ICD-10 diagnostic criterion of anhedonia
- No concomitant medication, specifically also free of antidepressants or other psychopharmaceuticals (for at least 2 weeks, 5 weeks for fluoxetin)
Who cannot join
- All participants:
- Current or history of neurological disease
- Current medical illness requiring treatment
- Pregnancy or current breastfeeding
- Current or former substance dependency
- Any contraindication for MRI
Show all 13Show fewer
- Failure to comply with the study protocol or to follow the instruction of the investigating team
- Failure to confirm effective use of contraception in females at least 8 weeks before and after study participation each
- First-degree relative with bipolar disorder or schizophrenia
- Specific to healthy subjects:
- Psychiatric diagnosis
- Specific to anhedonia patients:
- Psychiatric comorbidities excluding anxiety disorders and/or obsessive-compulsive disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Psychiatry and Psychotherapy, Division of General Psychiatry
Vienna, State of Vienna, 1160
Marie Spies, Priv.-Doz. DDr., +43 1 40400 ext. 73882, marie.spies@meduniwien.ac.at
Clemens Schmidt, MD, +43 1 40400 ext. 73882, clemens.schmidt@meduniwien.ac.at
About this study
Official title: Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects: A Randomized, Open-Label, Cross-Over Functional Magnetic Resonance Imaging Trial
The goal of this clinical trial is to systematically categorize potential prohedonic effects of psilocybin in patients with anhedonia in depression. The main questions it aims to answer are:
Primary Objectives
Read more
- Systematically categorize prohedonic effects (antianhedonic effects in patients with anhedonia in depression, increase in well-being in all participants).
- Test effects of psilocybin on brain network complexity measures during the hedonic experience using fMRI as a correlate for prohedonic (anti-anhedonic and well-being increasing) effects.
- Elucidate relevance of the psychedelic experience to these effects (clinical, behavioral, and imaging) in a pharmacological challenge using the 5-HT2A/D2 antagonist risperidone and extensive characterization of the psychedelic experience. Secondary Objectives 4. Test the differential effects of the psychedelic experience on fMRI paradigms measuring symptoms shown to be altered in anhedonia, more specifically reward processing and sexual arousal. 5. Test the relevance of neuroplasticity (BDNF) and inflammatory parameters to anti-anhedonic, well-being promoting, and brain network dynamic complexity effects. 6. Test the effects of the psychedelic experience on BDNF and inflammatory parameters.
Researchers will compare the effects of psilocybin in two separate sessions (one with psilocybin alone, one with co-administration of risperidone) in both patients with depression and anhedonia and healthy control participants.
Participants will:
- Take 25 mg of psilocybin p.o. in two sessions, in one of the two sessions they will take 1 mg risperidone p.o. before ingestion of psilocybin, to block psilocybin's acute psychedelic effects.
- Undergo 3 MRI sessions, one before the first psilocybin session ('baseline') and one session each on the day after each respective psilocybin session.
- Perform a variety of tasks during each fMRI session to asses the treatment's effects on anhedonia.
- Conditions
- Depression - Major Depressive Disorder, Anhedonia
- Being tested
- Psilocybin (Usona Institute), Risperidone 1 MG, MRI
- Keywords
- Psilocybin, Psilocin, Psychedelic, Anhedonia, Depression, MRI, fMRI, functional MRI, Pharmaco-Imaging, MDD, Serotonin, Risperidone
- Medical subject headings
- Anhedonia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (Usona Institute)Drug
Also called Psilocybin
Participants will recieve two doses of Psilocybin 25 mg to be taken orally over the course of the study.
Risperidone 1 MGDrug
Also called Risperidone, Risperdal
30 minutes before administration of psilocybin in one of the sessions to inhibit acute psychedelic effects
MRIDiagnostic test
Over the course of the study, participants will undergo three MRI measurement sessions.
- M1 (baseline, before treatment)
- M2 \& M3 (one day after each psilocybin session)
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin first, psilocybin + risperidone second | Experimental | Participants recieve psilocybin alone in the first session, psilocybin and risperidone in the second session Receives: Drug: Psilocybin (Usona Institute); Drug: Risperidone 1 MG; Diagnostic Test: MRI |
| Psilocybin + risperidone first, psilocybin second | Experimental | Participants recieve psilocybin and risperidone in the first session, psilocybin alone in the second session Receives: Drug: Psilocybin (Usona Institute); Drug: Risperidone 1 MG; Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic task
This task is designed to evoke and probe the nature and extent of the aesthetic experience. Two sets of stimuli will be presented. Each set consists of 20 pieces of self-selected music with 10 pieces inducing highly hedonic experiences and 10 neutral pieces. After stimulus presentation, subjects will rate how aesthetically moving the experience was, whether they experienced chills, and what the valence of the experience was on a Likert scale.
Measured: From enrolment until the second assessment session (up to 9 weeks after enrolment)
Monetary Incentive Delay (MID) Task
The MID task is established to evoke and assess reward and punishment, which are centrally involved in anhedonia. The task observes several stages of reward processing, i.e., reward prediction, anticipation and reward consumption. The aim of the paradigm is to maximize gain and avoid loss by fast reaction upon presentation of a target stimulus.
A trial starts with the presentation of a cue, indicating the potential gain or loss (e.g., -1€, +3€). After a variable delay of for instance 3-5 seconds the target stimulus is shown, and subjects press a button as fast as possible. If the reaction is within a given time limit the amount is gained or loss avoided. Otherwise, the amount is not gained or lost. Each button press is followed by immediate feedback, showing the outcome and the accumulated amount of money.
Measured: From enrolment until the last imaging session (up to 8 weeks after enrolment)
Sexual arousal task
This task has been implemented by our group to assess changes to sexual arousal, a central and burdensome, yet often understudied, component of anhedonia.
During this task, subjects are presented images intended to be sexually arousing and are instructed to denote the extent to which they find the image arousing.
Measured: From enrolment until the last imaging session (up to 8 weeks after enrolment)
Cognitive Flexibility Inventory (CFI)
The CFI is a 20-item self-report measure to assess two aspects of cognitive flexibility:
the adaptive ability to perceive multiple alternative explanations for life occurrences and the ability to generate multiple alternative solutions to difficult situations, as well as having an internal locus of control, or the tendency to perceive difficult situations as somewhat controllable.
Measured: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Intensity rating
A self-reported rating of the subjective intensity of the acute psychedelic experience will be collected after each medication session on a scale from 0 (not at all) to 4 (extreme).
Measured: From enrolment until the second medication session (up to 8 weeks after enrolment)
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
The WEMWBS is a self-report scale which will be used to assess mental well-being over the course of study participation.
Measured: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Beck-Depression-Inventory (BDI)
The BDI is a self-rated scale which is used to assess symptoms of depression.
Measured: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a observer-rated scale which is used to assess symptoms of depression.
Measured: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Dimensional Anhedonia Rating Scale (DARS)
The DARS is a self-report scale that measures anhedonia across four domains on a five-point-likert scale.
Measured: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Aesthetic Experiences Scale (AES)
The AES is a self-report scale which is used to assess aesthetic experiences in the form of 'aesthetic chills', the response of goose bumps and shivers in response to the arts.
Measured: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Temporal Experience of Pleasure Scale (TEPS)
The TEPS is a self-rating scale which is used to assess the experience of anticipatory and consummatory experiences of pleasure.
Measured: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Barcelona Music Reward Questionnaire (BMRQ)
The BMRQ is a psychometric scale designed to assess different factors underlying the experience of music reward, as measured through 20 items on a 5-point Likert scale.
Measured: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
5-Dimensional Altered States of Consciousness Rating (5D-ASC)
Properties of the psychedelic experience as assessed via the 5D-ASC, a a 94-item self-report scale that assesses the participants' alterations from normal waking Consciousness.
Measured: From enrolment until the second medication session (up to 8 weeks after enrolment)
Mystical Experience Questionnaire (MEQ30)
Properties of the psychedelic experience as assessed via the MEQ30, a 30 point self-rated scale, which is used to measure the intensity of common aspects of a psychedelic experience (divided into mystical, positive mood, transendence of time and space, and ineffability).
Measured: From enrolment until the second medication session (up to 8 weeks after enrolment)
Challenging Experience Questionnaire (CEQ)
Properties of the psychedelic experience as assessed via the Challenging Experience Questionnaire (CEQ), an instrument designed to measure challenging psychological experiences associated with the acute effects of psychedelics.
Measured: From enrolment until the second medication session (up to 8 weeks after enrolment)
Connor-Davidson Resilience Scale (CD-RISC)
The CD-RISC is a self-rating scale which is used to assess changes in study participants' resilience over the course of their participation.
Measured: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Secondary outcomes (4)
Cytokine panel
Changes in proinflammaotry cytokines, suchz as interleukin 6 and tumor necrosis factor alpha, which have been associated with depression and anhedonia, assessed via Legendplex cytokine panel
Measured: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Brain-derived neurotrophic factor (BDNF) concentration
Changes in blood markers which have been associated with depression and anhedonia, assessed via BDNF concentration.
Measured: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Neural activity
Neural activity during MID and sexual arousal task, assessed via fMRI measurement.
Measured: Over the course of the three MRI sessions (3-14 days after enrolment, 1 day after the first medication session, 6 weeks after the second measurement)
Brain network dynamic complexity
Brain complexity measures during the hedonic experience assessed with fMRI, as assesed via integrated information decomposition and BOLD variability
Measured: Over the course of the three MRI sessions (3-14 days after enrolment, 1 day after the first medication session, 6 weeks after the second measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Nov 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna
- Responsible party
- Principal investigator, Rupert Lanzenberger, Medical University of Vienna
- Investigators
- Marie Spies, Priv.-Doz. DDr., Principal investigator, Medical University of Vienna, Department of Psychiatry and Psychotherapy, Division of General Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490353
- Sponsor's protocol ID
- PSY-NIL-0016
- Other IDs
- 2024-519265-22-00
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects: A Randomized, Open-Label, Cross-Over Functional Magnetic Resonance Imaging Trial
- ClinicalTrials.gov ID
- NCT07490353
- Acronym / sponsor ID
- PSY-NIL-0016
- Conditions
- Depression - Major Depressive Disorder, Anhedonia
- Keywords
- Psilocybin, Psilocin, Psychedelic, Anhedonia, Depression, MRI, fMRI, functional MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of Vienna
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 24 Mar 2026 (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.
The goal of this clinical trial is to systematically categorize potential prohedonic effects of psilocybin in patients with anhedonia in depression. The main questions it aims to answer are:
Primary Objectives
- Systematically categorize prohedonic effects (antianhedonic effects in patients with anhedonia in depression, increase in well-being in all participants).
- Test effects of psilocybin on brain network complexity measures during the hedonic experience using fMRI as a correlate for prohedonic (anti-anhedonic and well-being increasing) effects.
- Elucidate relevance of the psychedelic experience to these effects (clinical, behavioral, and imaging) in a pharmacological challenge using the 5-HT2A/D2 antagonist risperidone and extensive characterization of the psychedelic experience. Secondary Objectives 4. Test the differential effects of the psychedelic experience on fMRI paradigms measuring symptoms shown to be altered in anhedonia, more specifically reward processing and sexual arousal. 5. Test the relevance of neuroplasticity (BDNF) and inflammatory parameters to anti-anhedonic, well-being promoting, and brain network dynamic complexity effects. 6. Test the effects of the psychedelic experience on BDNF and inflammatory parameters.
Researchers will compare the effects of psilocybin in two separate sessions (one with psilocybin alone, one with co-administration of risperidone) in both patients with depression and anhedonia and healthy control participants.
Participants will:
- Take 25 mg of psilocybin p.o. in two sessions, in one of the two sessions they will take 1 mg risperidone p.o. before ingestion of psilocybin, to block psilocybin's acute psychedelic effects.
- Undergo 3 MRI sessions, one before the first psilocybin session ('baseline') and one session each on the day after each respective psilocybin session.
- Perform a variety of tasks during each fMRI session to asses the treatment's effects on anhedonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin first, psilocybin + risperidone second | Experimental | Drug: Psilocybin (Usona Institute), Drug: Risperidone 1 MG, Diagnostic Test: MRIParticipants recieve psilocybin alone in the first session, psilocybin and risperidone in the second session |
| Psilocybin + risperidone first, psilocybin second | Experimental | Drug: Psilocybin (Usona Institute), Drug: Risperidone 1 MG, Diagnostic Test: MRIParticipants recieve psilocybin and risperidone in the first session, psilocybin alone in the second session |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- General health based on medical history, physical examination, blood draw, and electrocardiogram
- Age 18 to 55 years
- Right-handedness (due to potential lateralization effects of left-handed subjects)
- Willingness and competence to sign the informed consent form
- Normal BMI weight range (18.5-24.9)
Key exclusion criteria (13 listed)
- Current or history of neurological disease
- Current medical illness requiring treatment
- Pregnancy or current breastfeeding
- Current or former substance dependency
- Any contraindication for MRI
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 |
|---|---|---|
| Psilocybin (Usona Institute)Also: PsilocybinParticipants will recieve two doses of Psilocybin 25 mg to be taken orally over the course of the study. | Drug | Psilocybin + risperidone first, psilocybin second, Psilocybin first, psilocybin + risperidone second |
| Risperidone 1 MGAlso: Risperidone, Risperdal30 minutes before administration of psilocybin in one of the sessions to inhibit acute psychedelic effects | Drug | Psilocybin + risperidone first, psilocybin second, Psilocybin first, psilocybin + risperidone second |
| MRIOver the course of the study, participants will undergo three MRI measurement sessions. * M1 (baseline, before treatment) * M2 \& M3 (one day after each psilocybin session) | Diagnostic test | Psilocybin + risperidone first, psilocybin second, Psilocybin first, psilocybin + risperidone second |
Primary outcome
Aesthetic task
Time frame: From enrolment until the second assessment session (up to 9 weeks after enrolment)
This task is designed to evoke and probe the nature and extent of the aesthetic experience. Two sets of stimuli will be presented. Each set consists of 20 pieces of self-selected music with 10 pieces inducing highly hedonic experiences and 10 neutral pieces. After stimulus presentation, subjects will rate how aesthetically moving the experience was, whether they experienced chills, and what the valence of the experience was on a Likert scale.
Monetary Incentive Delay (MID) Task
Time frame: From enrolment until the last imaging session (up to 8 weeks after enrolment)
The MID task is established to evoke and assess reward and punishment, which are centrally involved in anhedonia. The task observes several stages of reward processing, i.e., reward prediction, anticipation and reward consumption. The aim of the paradigm is to maximize gain and avoid loss by fast reaction upon presentation of a target stimulus. A trial starts with the presentation of a cue, indicating the potential gain or loss (e.g., -1€, +3€). After a variable delay of for instance 3-5 seconds the target stimulus is shown, and subjects press a button as fast as possible. If the reaction is within a given time limit the amount is gained or loss avoided. Otherwise, the amount is not gained or lost. Each button press is followed by immediate feedback, showing the outcome and the accumulated amount of money.
Sexual arousal task
Time frame: From enrolment until the last imaging session (up to 8 weeks after enrolment)
This task has been implemented by our group to assess changes to sexual arousal, a central and burdensome, yet often understudied, component of anhedonia. During this task, subjects are presented images intended to be sexually arousing and are instructed to denote the extent to which they find the image arousing.
Cognitive Flexibility Inventory (CFI)
Time frame: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
The CFI is a 20-item self-report measure to assess two aspects of cognitive flexibility: the adaptive ability to perceive multiple alternative explanations for life occurrences and the ability to generate multiple alternative solutions to difficult situations, as well as having an internal locus of control, or the tendency to perceive difficult situations as somewhat controllable.
Intensity rating
Time frame: From enrolment until the second medication session (up to 8 weeks after enrolment)
A self-reported rating of the subjective intensity of the acute psychedelic experience will be collected after each medication session on a scale from 0 (not at all) to 4 (extreme).
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
The WEMWBS is a self-report scale which will be used to assess mental well-being over the course of study participation.
Beck-Depression-Inventory (BDI)
Time frame: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
The BDI is a self-rated scale which is used to assess symptoms of depression.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
The MADRS is a observer-rated scale which is used to assess symptoms of depression.
Dimensional Anhedonia Rating Scale (DARS)
Time frame: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
The DARS is a self-report scale that measures anhedonia across four domains on a five-point-likert scale.
Aesthetic Experiences Scale (AES)
Time frame: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
The AES is a self-report scale which is used to assess aesthetic experiences in the form of 'aesthetic chills', the response of goose bumps and shivers in response to the arts.
Temporal Experience of Pleasure Scale (TEPS)
Time frame: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
The TEPS is a self-rating scale which is used to assess the experience of anticipatory and consummatory experiences of pleasure.
Barcelona Music Reward Questionnaire (BMRQ)
Time frame: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
The BMRQ is a psychometric scale designed to assess different factors underlying the experience of music reward, as measured through 20 items on a 5-point Likert scale.
5-Dimensional Altered States of Consciousness Rating (5D-ASC)
Time frame: From enrolment until the second medication session (up to 8 weeks after enrolment)
Properties of the psychedelic experience as assessed via the 5D-ASC, a a 94-item self-report scale that assesses the participants' alterations from normal waking Consciousness.
Mystical Experience Questionnaire (MEQ30)
Time frame: From enrolment until the second medication session (up to 8 weeks after enrolment)
Properties of the psychedelic experience as assessed via the MEQ30, a 30 point self-rated scale, which is used to measure the intensity of common aspects of a psychedelic experience (divided into mystical, positive mood, transendence of time and space, and ineffability).
Challenging Experience Questionnaire (CEQ)
Time frame: From enrolment until the second medication session (up to 8 weeks after enrolment)
Properties of the psychedelic experience as assessed via the Challenging Experience Questionnaire (CEQ), an instrument designed to measure challenging psychological experiences associated with the acute effects of psychedelics.
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
The CD-RISC is a self-rating scale which is used to assess changes in study participants' resilience over the course of their participation.
4 secondary outcomes
Cytokine panel
Time frame: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Brain-derived neurotrophic factor (BDNF) concentration
Time frame: From enrolment until the last follow-up session (expected at about 12 weeks after enrolment)
Neural activity
Time frame: Over the course of the three MRI sessions (3-14 days after enrolment, 1 day after the first medication session, 6 weeks after the second measurement)
Brain network dynamic complexity
Time frame: Over the course of the three MRI sessions (3-14 days after enrolment, 1 day after the first medication session, 6 weeks after the second measurement)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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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.
Marie Spies, Priv.-Doz. DDr. principal investigator
Medical University of Vienna, Department of Psychiatry and Psychotherapy, Division of General Psychiatry
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 Psilocybin (Usona Institute), Risperidone 1 MG and MRI in people with Depression - Major Depressive Disorder and Anhedonia, run by Medical University of Vienna at 1 site in Austria.
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 13 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. 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 Austria. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Spies, Priv.-Doz. DDr. (+43 1 40400 ext. 73882, marie.spies@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aesthetic task (time frame: From enrolment until the second assessment session (up to 9 weeks after enrolment)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2026.