Spinal Cord InjuryPhase 1/2STOPNCT07251491
Psilocybin to Treat Depression in Spinal Cord Injury
A Phase 1/2 study testing Psilocybin (Usona Institute) in people with Spinal Cord Injury and Depression - Major Depressive Disorder, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Spinal Cord Injury, Depression - Major Depressive Disorder, Veteran
- What is being tested?
- Psilocybin (Usona Institute)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2026to 1 Mar 2028
- Phase
- Phase 1/2
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide informed consent
- Spinal cord injury for at least 1 year
- Confirmed diagnosis of depression
- At least 22 years of age at time of consent
- At least 50 kg (110 lbs.) body weight
- Fully independent from ventilatory support (ventilator or diaphragm pacer)
Show all 12Show fewer
- Fluent in speaking and reading English
- Able to swallow pills
- Agree to have study visits recorded with audio and video
- Agree to release outside medical and psychiatric records
- Able and willing to taper off antidepressant, under clinician supervision
- Agree to use adequate contraceptive methods
Who cannot join
- Are not able to give adequate informed consent
- Have used psilocybin or another psychedelic within 6 months
- Have received Electroconvulsive Therapy (ECT) within 12 weeks
- Have used ketamine within 12 weeks
- Have a history of Bipolar I Disorder
- Have a current eating disorder
Show all 12Show fewer
- Have a current severe alcohol or cannabis use disorder within the 6 months
- Have an illicit drug or prescription drug substance use disorder within 12 months
- Current serious suicide risk
- History of heart attack, aneurysm, or stroke
- Uncontrolled hypertension
- Are pregnant or nursing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
James J. Peters Department of Veterans Affairs Medical Center
The Bronx, New York, 10468
Thomas W Sutor, PhD, 718-584-9000 ext. 5129, thomas.sutor@mountsinai.org
Dylan C Arnero, MS, 718-584-9000 ext. 5124, Dylan.Arnero@va.gov
About this study
Official title: Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury
The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg).
The main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with SCI? These may include pain, muscle spasms, symptoms of depression, and symptoms of low or high blood pressure. The investigators will also measure how well people with SCI tolerate the psychedelic experience, and compare responses between the low (5mg), medium (10mg), and high (25mg) doses.
Read more
Participants will:
- Agree to be enrolled in the study for up to 13 months.
- Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy.
- Agree to complete follow-up study visits, including in-person visits to the James J Peters VA Medical Center, located in the Bronx, New York and remote visits.
- Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events.
Read the detailed description
Background: Depression may be explained partly by decreased signaling of serotonin in the nervous system. Psilocybin, the active component of 'magic mushrooms', is a drug that activates serotonin pathways in the nervous system. Some scientists think psilocybin could help people with major depression, but it is not currently approved as a medicine in the United States. People with spinal cord injuries (SCI) often feel depressed, even more commonly than people without injuries. People with SCI have not been included in psilocybin studies. The goals of this study are first to see if psilocybin can be safely administered, and to determine if psilocybin can help improve symptoms of depression in people with SCI. Study Goals: The investigators will look at how safe psilocybin is for people with SCI, how people with SCI respond to different doses, and whether it helps reduce the severity of depression and other problems, like pain or muscle spasms. The study team will also check to see if psilocybin improves quality of life and wellbeing. The study will track these effects for a year after participants receive psilocybin. Study Plan: Thirty people with chronic SCI with a depressive disorder will be asked to join-15 with paraplegia and 15 with tetraplegia. They will be split into three groups to try different psilocybin doses: low (5mg), medium (10mg), and high (25mg). The study will take a stepwise approach to safety, but participants will not know the dose of psilocybin they receive. There will be at least 16 study visits, including medical and mental health check-ups, psilocybin assisted therapy, primary study endpoint and follow-up visits. What Will Be Measured: The study focus is to see if psilocybin is safe and tolerable in people with SCI. The study will track side effects, how people feel, and any changes in mood, pain, medication use, or body reactions. Doctors will check for problems like chest pain, high blood pressure, and changes in suicidal thoughts. The study team will also measure satisfaction with the therapy, experiences during the psilocybin sessions, and changes in depression. Why It Matters: Some people wrongly believe depression is just a normal part of living with SCI, so their depression may not be adequately treated. Also, people with SCI often can't join trials of new treatments because they have other health problems. Psilocybin could help treat depression and may improve many body functions affected by SCI if it is shown to be safe and effective.
- Being tested
- Psilocybin (Usona Institute)
- Keywords
- Tetraplegia, Paraplegia, Psychosocial Wellbeing, Depression, Neuropathic Pain, Psychedelics
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia, Paraplegia, Depression, Neuralgia
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 Magic Mushrooms
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin Low Dose | Experimental | Psilocybin 5mg Receives: Drug: Psilocybin (Usona Institute) |
| Psilocybin Medium Dose | Experimental | Psilocybin 10mg Receives: Drug: Psilocybin (Usona Institute) |
| Psilocybin High Dose | Experimental | Psilocybin 25mg Receives: Drug: Psilocybin (Usona Institute) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events as Assessed by the Adverse Events Log.
The Adverse Events Log will be captured by the research team at screening, before and after medication taper (if needed), weekly during the taper, at each of the three preparatory and three integration sessions, at 44 days post dose, and at all remote and in-person follow-up visits; 16 assessments in total.
Measured: Screening through study completion, an average of 13 months.
Secondary outcomes (2)
Clinician rated change from baseline (V1) in the Montgomery-Asberg Depression Rating Scale (MADRS) score at 44(+/-7) days post psilocybin dose (V9).
The MADRS is a ten-item diagnostic questionnaire that includes questions related to symptoms of (1) apparent sadness; (2) reported sadness; (3) inner tension; (4) reduced sleep; (5) reduced appetite; (6) concentration difficulties; (7) lassitude; (8) inability to feel; (9) pessimistic thoughts; and (10) suicidal thoughts. Each item yields a score of 0 to 6, with higher scores reflecting more severe depression. MADRS scores correspond to 0-6 (normal or no depression), 7-19 (mild depression), 20-30 (moderate depression), 31-39 (severe depression), and 40-60 (extremely severe depression). Higher scores are indicative of higher levels of depression, range of scores 0-60.
Measured: Baseline to 44 days post psilocybin.
Self reported change in depression severity score on the Beck Depression Inventory (BDI-II) from baseline (V1) to 44(+/-7) days post psilocybin (V9).
The BDI-II consists of four answer choices that are scored from 0 (no symptom) to 3 (severe symptom). Total BDI scores correspond to 0-9 (minimal depression), 10-18 (mild depression), 19-29 (moderate depression) and 30-63 (severe depression). Higher scores are indicative of higher levels of depression, range of scores 0-63.
Measured: Baseline to 44 days post psilocybin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start6 Aug 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- psilocybin 5mg psilocybin 10mg psilocybin 25mg
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Bronx Veterans Medical Research Foundation, Inc, Usona Institute, United States Department of Defense
- Responsible party
- Principal investigator, Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Jill M Wecht, EdD, Principal investigator, James J Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251491
- Sponsor's protocol ID
- 1872390
- Other IDs
- SC240097
- Acronym
- STOP
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If data will not be shared it is due to restrictive policies within the VA.
Publications
Lyes M, Yang KH, Castellanos J, Furnish T. Microdosing psilocybin for chronic pain: a case series. Pain. 2023 Apr 1;164(4):698-702. doi: 10.1097/j.pain.0000000000002778. Epub 2022 Sep 5.
PubMed 36066961Abrams SK, Rabinovitch BS, Zafar R, Aziz AS, Cherup NP, McMillan DW, Nielson JL, Lewis EC. Persons With Spinal Cord Injury Report Peripherally Dominant Serotonin-Like Syndrome After Use of Serotonergic Psychedelics. Neurotrauma Rep. 2023 Aug 22;4(1):543-550. doi: 10.1089/neur.2023.0022. eCollection 2023.
PubMed 37636336Liu Y, Collins C, Wang K, Xie X, Bie R. The prevalence and trend of depression among veterans in the United States. J Affect Disord. 2019 Feb 15;245:724-727. doi: 10.1016/j.jad.2018.11.031. Epub 2018 Nov 5.
PubMed 30699861Smith BM, Weaver FM, Ullrich PM. Prevalence of depression diagnoses and use of antidepressant medications by veterans with spinal cord injury. Am J Phys Med Rehabil. 2007 Aug;86(8):662-71. doi: 10.1097/PHM.0b013e318114cb6d.
PubMed 17667197Sloshower J, Skosnik PD, Safi-Aghdam H, Pathania S, Syed S, Pittman B, D'Souza DC. Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial. J Psychopharmacol. 2023 Jul;37(7):698-706. doi: 10.1177/02698811231154852. Epub 2023 Mar 20.
PubMed 36938991Goodwin GM, Aaronson ST, Alvarez O, Atli M, Bennett JC, Croal M, DeBattista C, Dunlop BW, Feifel D, Hellerstein DJ, Husain MI, Kelly JR, Lennard-Jones MR, Licht RW, Marwood L, Mistry S, Palenicek T, Redjep O, Repantis D, Schoevers RA, Septimus B, Simmons HJ, Soares JC, Somers M, Stansfield SC, Stuart JR, Tadley HH, Thiara NK, Tsai J, Wahba M, Williams S, Winzer RI, Young AH, Young MB, Zisook S, Malievskaia E. Single-dose psilocybin for a treatment-resistant episode of major depression: Impact on patient-reported depression severity, anxiety, function, and quality of life. J Affect Disord. 2023 Apr 14;327:120-127. doi: 10.1016/j.jad.2023.01.108. Epub 2023 Feb 4.
PubMed 36740140Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.
PubMed 36322843Khazaeipour Z, Taheri-Otaghsara SM, Naghdi M. Depression Following Spinal Cord Injury: Its Relationship to Demographic and Socioeconomic Indicators. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):149-55. doi: 10.1310/sci2102-149. Epub 2015 Apr 12.
PubMed 26364284Krause JS, Kemp B, Coker J. Depression after spinal cord injury: relation to gender, ethnicity, aging, and socioeconomic indicators. Arch Phys Med Rehabil. 2000 Aug;81(8):1099-109. doi: 10.1053/apmr.2000.7167.
PubMed 10943762
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07251491
- Acronym / sponsor ID
- STOP / 1872390
- Keywords
- Tetraplegia, Paraplegia, Psychosocial Wellbeing, Depression, Neuropathic Pain, Psychedelics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Bronx Veterans Medical Research Foundation, Inc, Usona Institute, United States Department of Defense
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 26 Nov 2025 (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 main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg).
The main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with SCI? These may include pain, muscle spasms, symptoms of depression, and symptoms of low or high blood pressure. The investigators will also measure how well people with SCI tolerate the psychedelic experience, and compare responses between the low (5mg), medium (10mg), and high (25mg) doses.
Participants will:
- Agree to be enrolled in the study for up to 13 months.
- Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy.
- Agree to complete follow-up study visits, including in-person visits to the James J Peters VA Medical Center, located in the Bronx, New York and remote visits.
- Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events.
Detailed description
Background: Depression may be explained partly by decreased signaling of serotonin in the nervous system. Psilocybin, the active component of 'magic mushrooms', is a drug that activates serotonin pathways in the nervous system. Some scientists think psilocybin could help people with major depression, but it is not currently approved as a medicine in the United States. People with spinal cord injuries (SCI) often feel depressed, even more commonly than people without injuries. People with SCI have not been included in psilocybin studies. The goals of this study are first to see if psilocybin can be safely administered, and to determine if psilocybin can help improve symptoms of depression in people with SCI. Study Goals: The investigators will look at how safe psilocybin is for people with SCI, how people with SCI respond to different doses, and whether it helps reduce the severity of depression and other problems, like pain or muscle spasms. The study team will also check to see if psilocybin improves quality of life and wellbeing. The study will track these effects for a year after participants receive psilocybin. Study Plan: Thirty people with chronic SCI with a depressive disorder will be asked to join-15 with paraplegia and 15 with tetraplegia. They will be split into three groups to try different psilocybin doses: low (5mg), medium (10mg), and high (25mg). The study will take a stepwise approach to safety, but participants will not know the dose of psilocybin they receive. There will be at least 16 study visits, including medical and mental health check-ups, psilocybin assisted therapy, primary study endpoint and follow-up visits. What Will Be Measured: The study focus is to see if psilocybin is safe and tolerable in people with SCI. The study will track side effects, how people feel, and any changes in mood, pain, medication use, or body reactions. Doctors will check for problems like chest pain, high blood pressure, and changes in suicidal thoughts. The study team will also measure satisfaction with the therapy, experiences during the psilocybin sessions, and changes in depression. Why It Matters: Some people wrongly believe depression is just a normal part of living with SCI, so their depression may not be adequately treated. Also, people with SCI often can't join trials of new treatments because they have other health problems. Psilocybin could help treat depression and may improve many body functions affected by SCI if it is shown to be safe and effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- psilocybin 5mg psilocybin 10mg psilocybin 25mg
| Arm | Type | Receives |
|---|---|---|
| Psilocybin Low Dose | Experimental | Drug: Psilocybin (Usona Institute)Psilocybin 5mg |
| Psilocybin Medium Dose | Experimental | Drug: Psilocybin (Usona Institute)Psilocybin 10mg |
| Psilocybin High Dose | Experimental | Drug: Psilocybin (Usona Institute)Psilocybin 25mg |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able and willing to provide informed consent
- Spinal cord injury for at least 1 year
- Confirmed diagnosis of depression
- At least 22 years of age at time of consent
- At least 50 kg (110 lbs.) body weight
Key exclusion criteria (12 listed)
- Are not able to give adequate informed consent
- Have used psilocybin or another psychedelic within 6 months
- Have received Electroconvulsive Therapy (ECT) within 12 weeks
- Have used ketamine within 12 weeks
- Have a history of Bipolar I 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 |
|---|---|---|
| Psilocybin (Usona Institute)Also: Magic MushroomsOral capsules | Drug | Psilocybin High Dose, Psilocybin Low Dose, Psilocybin Medium Dose |
Primary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by the Adverse Events Log.
Time frame: Screening through study completion, an average of 13 months.
The Adverse Events Log will be captured by the research team at screening, before and after medication taper (if needed), weekly during the taper, at each of the three preparatory and three integration sessions, at 44 days post dose, and at all remote and in-person follow-up visits; 16 assessments in total.
2 secondary outcomes
Clinician rated change from baseline (V1) in the Montgomery-Asberg Depression Rating Scale (MADRS) score at 44(+/-7) days post psilocybin dose (V9).
Time frame: Baseline to 44 days post psilocybin.
Self reported change in depression severity score on the Beck Depression Inventory (BDI-II) from baseline (V1) to 44(+/-7) days post psilocybin (V9).
Time frame: Baseline to 44 days post psilocybin.
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 10 Aug 2026.
- Background: PubMed 36066961Lyes M, Yang KH, Castellanos J, Furnish T. Microdosing psilocybin for chronic pain: a case series. Pain. 2023 Apr 1;164(4):698-702. doi: 10.1097/j.pain.0000000000002778. Epub 2022 Sep 5.
- Background: PubMed 37636336Abrams SK, Rabinovitch BS, Zafar R, Aziz AS, Cherup NP, McMillan DW, Nielson JL, Lewis EC. Persons With Spinal Cord Injury Report Peripherally Dominant Serotonin-Like Syndrome After Use of Serotonergic Psychedelics. Neurotrauma Rep. 2023 Aug 22;4(1):543-550. doi: 10.1089/neur.2023.0022. eCollection 2023.
- Background: PubMed 30699861Liu Y, Collins C, Wang K, Xie X, Bie R. The prevalence and trend of depression among veterans in the United States. J Affect Disord. 2019 Feb 15;245:724-727. doi: 10.1016/j.jad.2018.11.031. Epub 2018 Nov 5.
- Background: PubMed 17667197Smith BM, Weaver FM, Ullrich PM. Prevalence of depression diagnoses and use of antidepressant medications by veterans with spinal cord injury. Am J Phys Med Rehabil. 2007 Aug;86(8):662-71. doi: 10.1097/PHM.0b013e318114cb6d.
- Background: PubMed 36938991Sloshower J, Skosnik PD, Safi-Aghdam H, Pathania S, Syed S, Pittman B, D'Souza DC. Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial. J Psychopharmacol. 2023 Jul;37(7):698-706. doi: 10.1177/02698811231154852. Epub 2023 Mar 20.
- Background: PubMed 36740140Goodwin GM, Aaronson ST, Alvarez O, Atli M, Bennett JC, Croal M, DeBattista C, Dunlop BW, Feifel D, Hellerstein DJ, Husain MI, Kelly JR, Lennard-Jones MR, Licht RW, Marwood L, Mistry S, Palenicek T, Redjep O, Repantis D, Schoevers RA, Septimus B, Simmons HJ, Soares JC, Somers M, Stansfield SC, Stuart JR, Tadley HH, Thiara NK, Tsai J, Wahba M, Williams S, Winzer RI, Young AH, Young MB, Zisook S, Malievskaia E. Single-dose psilocybin for a treatment-resistant episode of major depression: Impact on patient-reported depression severity, anxiety, function, and quality of life. J Affect Disord. 2023 Apr 14;327:120-127. doi: 10.1016/j.jad.2023.01.108. Epub 2023 Feb 4.
- Background: PubMed 36322843Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.
- Background: PubMed 26364284Khazaeipour Z, Taheri-Otaghsara SM, Naghdi M. Depression Following Spinal Cord Injury: Its Relationship to Demographic and Socioeconomic Indicators. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):149-55. doi: 10.1310/sci2102-149. Epub 2015 Apr 12.
- Background: PubMed 10943762Krause JS, Kemp B, Coker J. Depression after spinal cord injury: relation to gender, ethnicity, aging, and socioeconomic indicators. Arch Phys Med Rehabil. 2000 Aug;81(8):1099-109. doi: 10.1053/apmr.2000.7167.
- Individual participant dataSharing planned: Undecided. If data will not be shared it is due to restrictive policies within the VA.
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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.
Jill M Wecht, EdD principal investigator
James J Peters VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psilocybin (Usona Institute) in people with Spinal Cord Injury and Depression - Major Depressive Disorder, run by James J. Peters Veterans Affairs Medical Center 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 12 inclusion and 12 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 10 Aug 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 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 combined 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.
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?
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 Thomas W Sutor, PhD (718-584-9000 ext. 5129, Thomas.Sutor@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events as Assessed by the Adverse Events Log. (time frame: Screening through study completion, an average of 13 months.). 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 NCT07251491, which also lists 9 linked publications.
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 10 Aug 2026.