Major Depressive DisorderPhase 2PET-SPIDERNCT05601648
PET Synaptogenesis After Psilocybin In DEpression Recovery
A Phase 2 study testing Psilocybin in people with Major Depressive Disorder and Anhedonia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Participants with depression will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo positron emission tomography (PET) imaging before and one week after psilocybin using a marker of synaptic density. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Anhedonia
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Jul 2025
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 65 years of age;
- Able to provide informed consent
- Women of childbearing age must agree to be on two forms of contraception and men are required to utilize at least one form of contraception
- Willingness to comply and be available for all study requirements, including psychological, cognitive, and imaging for the duration of the study
- Meeting DSM-5 criteria for major depressive disorder and current depressive episode
- Snaith-Hamilton Anhedonia Pleasure Scale (SHAPS) ≥ 6 points
- Willing and able to taper and/or discontinue current psychotropic medications
Who cannot join
- Women who are pregnant or who intend to become pregnant or nurse during the study duration.
- Presence of psychiatric conditions that are contraindications to psilocybin exposure (e.g., personal or first degree relative with history of schizophrenia spectrum or bipolar disorder);
- Use of psychotropic medication that may interact with psilocybin (TCA, MAOi, antipsychotic/neuroleptics, anti-epileptic/mood stabilizer, lithium, SSRI, SNRI, Mirtazapine, Buproprion, Vortioxetine).
- Recent use of psychedelics (psilocybin, LSD, ayahuasca, mescaline; past 5 years); or prior severe adverse reactions to psychedelics
- Active suicidal ideation or history of a suicide attempt.
- Presence of medical conditions that are contraindications to psilocybin exposure (e.g., neurological conditions or severe hypertension, severe and/or unstable metabolic or cardiovascular conditions);
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- Current medical conditions that are known to increase risk of severe coronavirus infection or deemed by a study physician to put an individual at high risk (i.e., cancer, COPD, obesity, immunosuppression, type 2 diabetes, serious heart conditions, sickle cell disease, asthma);
- Presence of contraindications to PET or MRI scanning (renal disease, implantable devices, bone hardware, some IUDs);
- Body mass index >30 (due to MRI confounds).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: SV2A Marker of Synaptogenesis in a Clinical Trial of Psilocybin for Depression
Participants with depression will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo positron emission tomography (PET) imaging before and one week after psilocybin using a marker of synaptic density. This design allows us to assess the relationship between neurotrophic, and antidepressant effects produced by psilocybin.
Read the detailed description
The investigators are studying the neurotrophic effects of psilocybin using 11C-UCB-J, a PET marker for synaptogenesis. Psilocybin is a naturally occurring psychedelic and exerts perceptual effects via 5-HT2A receptor agonism. Psilocybin has gained a great deal of attention as a tool for psychiatric treatment, with clinical trials demonstrating symptom relief after a single dose that is immediate and persists for months. Recognizing the therapeutic potential of psilocybin, the US Food and Drug Administration granted breakthrough therapy status to the Usona Institute for Phase 2 testing of psilocybin in depression. Animal models suggest that psychedelics exert antidepressant effects by producing a rapid and powerful neurotrophic response in the brain.
The investigators will enroll patients with major depressive disorder and anhedonia. Participants will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo PET imaging before and one week after drug using 11C-UCB-J, a radiotracer that binds to SV2A - a marker of synaptic density and synaptogenesis. This design allows the investigators to assess the relationship between neurotrophic, and antidepressant effects produced by psilocybin.
- Conditions
- Major Depressive Disorder, Anhedonia
- Being tested
- Psilocybin
- Keywords
- Psilocybin, 11C-UCB-J, SV2A
- Medical subject headings
- Depressive Disorder, Major, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Psilocybin (25mg tablet) plus supportive psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | Eligible adults to undergo a single drug session with psilocybin (25mg tablet) plus supportive psychotherapy Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synaptogenesis in hippocampus
Change in 11C-UCB-J signal in the hippocampus from baseline to post-treatment PET scans.
Measured: 7 days after psilocybin
Synaptogenesis in medial prefrontal cortex
Change in 11C-UCB-J signal in the medial prefrontal cortex from baseline to post-treatment PET scans.
Measured: 7 days after psilocybin
Secondary outcomes (2)
Change in major depressive disorder symptoms
Change in Montgomery-Asberg Depression Rating Scale (MADRS) - score range 0-60 (higher score equals greater severity of depressive symptoms).
Measured: 7 days after psilocybin
Change in anhedonia symptoms
Change in Snaith-Hamilton Anhedonia Pleasure Scale (SHAPS) - is a 14 item self-report measure assessing pleasure response/hedonic experience across domains. The SHAPS measures both anticipation and experience of pleasure. A score is obtained by making binary (disagree/strongly disagree =1) and summing the 14 items - range 0-14, greater than 3 is considered abnormal.
Measured: 7 days after psilocybin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Why it stopped: Due to negative results in similar trials using 11C-UCB-J
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label treatment study, no placebo.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601648
- Sponsor's protocol ID
- WashU20220654925
- Acronym
- PET-SPIDER
- Status last verified
- Jan 2023
- First submitted
- 17 Oct 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SV2A Marker of Synaptogenesis in a Clinical Trial of Psilocybin for Depression
- ClinicalTrials.gov ID
- NCT05601648
- Acronym / sponsor ID
- PET-SPIDER / WashU20220654925
- Conditions
- Major Depressive Disorder, Anhedonia
- Keywords
- Psilocybin, 11C-UCB-J, SV2A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to negative results in similar trials using 11C-UCB-J
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 1 Nov 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.
Participants with depression will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo positron emission tomography (PET) imaging before and one week after psilocybin using a marker of synaptic density. This design allows us to assess the relationship between neurotrophic, and antidepressant effects produced by psilocybin.
Detailed description
The investigators are studying the neurotrophic effects of psilocybin using 11C-UCB-J, a PET marker for synaptogenesis. Psilocybin is a naturally occurring psychedelic and exerts perceptual effects via 5-HT2A receptor agonism. Psilocybin has gained a great deal of attention as a tool for psychiatric treatment, with clinical trials demonstrating symptom relief after a single dose that is immediate and persists for months. Recognizing the therapeutic potential of psilocybin, the US Food and Drug Administration granted breakthrough therapy status to the Usona Institute for Phase 2 testing of psilocybin in depression. Animal models suggest that psychedelics exert antidepressant effects by producing a rapid and powerful neurotrophic response in the brain.
The investigators will enroll patients with major depressive disorder and anhedonia. Participants will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo PET imaging before and one week after drug using 11C-UCB-J, a radiotracer that binds to SV2A - a marker of synaptic density and synaptogenesis. This design allows the investigators to assess the relationship between neurotrophic, and antidepressant effects produced by psilocybin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label treatment study, no placebo.
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: PsilocybinEligible adults to undergo a single drug session with psilocybin (25mg tablet) plus supportive psychotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women between 18 and 65 years of age;
- Able to provide informed consent
- Women of childbearing age must agree to be on two forms of contraception and men are required to utilize at least one form of contraception
- Willingness to comply and be available for all study requirements, including psychological, cognitive, and imaging for the duration of the study
- Meeting DSM-5 criteria for major depressive disorder and current depressive episode
Key exclusion criteria (9 listed)
- Women who are pregnant or who intend to become pregnant or nurse during the study duration.
- Presence of psychiatric conditions that are contraindications to psilocybin exposure (e.g., personal or first degree relative with history of schizophrenia spectrum or bipolar disorder);
- Use of psychotropic medication that may interact with psilocybin (TCA, MAOi, antipsychotic/neuroleptics, anti-epileptic/mood stabilizer, lithium, SSRI, SNRI, Mirtazapine, Buproprion, Vortioxetine).
- Recent use of psychedelics (psilocybin, LSD, ayahuasca, mescaline; past 5 years); or prior severe adverse reactions to psychedelics
- Active suicidal ideation or history of a suicide attempt.
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 |
|---|---|---|
| PsilocybinPsilocybin (25mg tablet) plus supportive psychotherapy | Drug | Psilocybin |
Primary outcome
Synaptogenesis in hippocampus
Time frame: 7 days after psilocybin
Change in 11C-UCB-J signal in the hippocampus from baseline to post-treatment PET scans.
Synaptogenesis in medial prefrontal cortex
Time frame: 7 days after psilocybin
Change in 11C-UCB-J signal in the medial prefrontal cortex from baseline to post-treatment PET scans.
2 secondary outcomes
Change in major depressive disorder symptoms
Time frame: 7 days after psilocybin
Change in anhedonia symptoms
Time frame: 7 days after psilocybin
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Major Depressive Disorder and Anhedonia, run by Washington University School of Medicine at 1 site in United States.
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 7 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: withdrawn, as of the sponsor's last update on 30 Jan 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Synaptogenesis in hippocampus (time frame: 7 days after psilocybin). The study lists 2 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 30 Jan 2023.