DemoralizationPhase 1NCT06818994
Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer
A Phase 1 study testing Psilocybin-assisted Psychotherapy in people with Demoralization and Safety, run by Gustavo Vazquez at 1 site in Canada.
Trial summary
Demoralization syndrome is frequently present in palliative care and oncology patients. In particular, up to a third of patients diagnosed with cancer will experience demoralization due to their illness. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Demoralization, Safety
- What is being tested?
- Psilocybin-assisted Psychotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2026to 1 Jun 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with advanced stage cancer (stages 3 and 4)
- Aged between 18 and 70 years.
- Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30
- English proficiency
- Ability to understand and the willingness to sign a written informed consent document.
- Individuals of child-bearing potential who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled in this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of psilocybin administration.
Who cannot join
- Condition impairing oral intake or digestive absorption.
- Primary brain tumor.
- Presence of delirium.
- Significant suicide risk as defined by suicidal ideation with intent and a plan.
- Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history.
- Patients with first-degree relatives with schizophrenia or bipolar disorder
Show all 19Show fewer
- Previous diagnosis of epilepsy, stroke or Transient Ischemic Attack (TIA), dementia, and Parkinson's disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin.
- Other personal circumstances and behavior that would limit compliance with study requirements or that are judged by the study psychiatrist and/or principal investigator to be incompatible with establishing rapport or safe exposure to psilocybin.
- Potential for adverse drug-drug interactions. Concomitant medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. These include the following:
- MAO inhibitors
- Patients currently on antipsychotics (e.g. first and second generation) when taken regularly (6 weeks or less prior to screening visit)
- Mood stabilizers (e.g. lithium, valproic acid, lamotrigine)
- Aldehyde dehydrogenase inhibitors (e.g. disulfiram)
- Significant inhibitors of UGT 1A0 or UGT 1A10
- Patients who have elevated AST and ALT five times above the normal laboratory limit on their last available bloodwork performed at screening and patients with symptoms suggestive of liver failure including confusion, asterixis or jaundice.
- Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal condition or any other unstable condition that, in the opinion of the principal investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study. This may include but is not limited to clinical symptoms or recent history of significant tachyarrhythmias; severe angina or myocardial ischemia; poorly controlled congestive heart failure; poorly controlled hypertension; poorly controlled hypo- or hyperthyroidism; uncontrolled diabetes; severe renal or liver dysfunction; acute respiratory failure; sepsis; history of cerebral aneurysms; glaucoma; increased intracranial pressure and any intracranial mass.
- Women who are pregnant, nursing, or planning a pregnancy.
- Use of a classic psychedelic or MDMA in the last 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Queen's University
Kingston, Ontario, K7L 3N6
Vazquez Gustavo, MD, PhD, 613-544-4900 ext. 51214, vazquezg@providencecare.ca
Carolina Hernandorena, MD
About this study
Official title: Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer: a Pilot Study
Demoralization syndrome is frequently present in palliative care and oncology patients. In particular, up to a third of patients diagnosed with cancer will experience demoralization due to their illness. The relevance of demoralization syndrome in oncology is tied to this syndrome's association with other mental health ailments such as depression, anxiety, suicidal ideation, and quality of life. Unfortunately, so far no pharmacological strategy has been devised for demoralization, and only a few psychotherapeutic approaches have been trialed in this population, though no psychotherapeutic treatments have been tested for demoralization specifically. The new wave of psychedelic research has been showing encouraging results in a broad spectrum of psychiatric diagnosis, including depression and anxiety in patients diagnosed with cancer and other life-threatening diseases. To date, no clinical trials have been published in which the potential therapeutic effects of psychedelics are explored for the treatment of demoralization syndrome. The aim of this open label pilot study is to assess the safety and efficacy of psilocybin-assisted psychotherapy as a treatment for demoralization syndrome in patients diagnosed with cancer. Fifteen participants between the ages of 18 to 70 years with advanced stage cancer and demoralization syndrome will be enrolled in a treatment program which will include 6 psychotherapeutic sessions and one psilocybin (25 mg) dosing session. Our outcome of interest will be a decrease in demoralization, as measured by the Demoralization Scale at baseline and at the end of the study, and adverse events registration. Other measures of interest include Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and the Columbia Suicide Severity Rating Scale. Those patients with partial response a month after the psilocybin intervention will be offered the possibility of a second psilocybin 25 mg dosing session.
- Conditions
- Demoralization, Safety
- Being tested
- Psilocybin-assisted Psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin-assisted PsychotherapyDrug
The intervention will be psilocybin-assisted psychotherapy. The first treatment period will include four preparation sessions with Managing Cancer and Living Meaningfully (CALM) therapy elements. The psilocybin dosing session will take place after these preparation sessions are completed. The dosing session will include an in-person visit lasting approximately 8 hours in which the participant will receive a capsule of psilocybin 25 mg under constant supervision of therapists. The following day, the first integration session will take place and two weeks later the second integration session along with CALM will be conducted. Participants who show a partial response will be offered a second dosing session, entering the second treatment period. The second treatment period includes a second dosing session using the same dose and safety measures as the first one. It will also be followed by an integration session the following day, and a second integration session with CALM two weeks later.
| Study group | Role | What they receive |
|---|---|---|
| advanced cancer participants | Experimental | Not described Receives: Drug: Psilocybin-assisted Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demoralization Scale
Demoralization Scale is a 24-item Likert scale. Items are scored on a 5-point scale from 0 (never) to 4 (all the time), in which higher scores are associated with higher demoralization. Scores can range from 0 to 96. A cut-off point of ≥ 30 in this scale is considered as high demoralization and will be used for participant inclusion in the study.
Measured: From enrollment to the end of the follow up period at week 16 or 19
Adverse Events (AEs) and Serious Adverse Events (SAEs) register
Measured: From enrollment to the end of the follow up period at week 16 or 19
Secondary outcomes (3)
Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale is a 14-item Likert scale. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56. Higher scores are associated with increased symptom severity, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: From enrollment to the end of the follow up period at week 16 or 19
Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale is a 17-item Likert scale. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-68. Higher scores are associated with increased symptom severity.
Measured: From enrollment to the end of the follow up period at week 16 or 19
Columbia Suicide Severity Rating Scale
Columbia Suicide Severity Rating Scale includes ten categories, all of which maintain binary responses (yes/no) to indicate a presence or absence of suicidal behavior. Affirmative answers are associated with higher suicidality
Measured: From enrollment to the end of the follow up period at week 16 or 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DemoralizationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustavo Vazquez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gustavo Vazquez, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818994
- Sponsor's protocol ID
- 65563
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer: a Pilot Study
- ClinicalTrials.gov ID
- NCT06818994
- Acronym / sponsor ID
- 65563
- Conditions
- Demoralization, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Gustavo VazquezUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 11 Feb 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.
Demoralization syndrome is frequently present in palliative care and oncology patients. In particular, up to a third of patients diagnosed with cancer will experience demoralization due to their illness. The relevance of demoralization syndrome in oncology is tied to this syndrome's association with other mental health ailments such as depression, anxiety, suicidal ideation, and quality of life. Unfortunately, so far no pharmacological strategy has been devised for demoralization, and only a few psychotherapeutic approaches have been trialed in this population, though no psychotherapeutic treatments have been tested for demoralization specifically. The new wave of psychedelic research has been showing encouraging results in a broad spectrum of psychiatric diagnosis, including depression and anxiety in patients diagnosed with cancer and other life-threatening diseases. To date, no clinical trials have been published in which the potential therapeutic effects of psychedelics are explored for the treatment of demoralization syndrome. The aim of this open label pilot study is to assess the safety and efficacy of psilocybin-assisted psychotherapy as a treatment for demoralization syndrome in patients diagnosed with cancer. Fifteen participants between the ages of 18 to 70 years with advanced stage cancer and demoralization syndrome will be enrolled in a treatment program which will include 6 psychotherapeutic sessions and one psilocybin (25 mg) dosing session. Our outcome of interest will be a decrease in demoralization, as measured by the Demoralization Scale at baseline and at the end of the study, and adverse events registration. Other measures of interest include Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and the Columbia Suicide Severity Rating Scale. Those patients with partial response a month after the psilocybin intervention will be offered the possibility of a second psilocybin 25 mg dosing session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| advanced cancer participants | Experimental | Drug: Psilocybin-assisted Psychotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with advanced stage cancer (stages 3 and 4)
- Aged between 18 and 70 years.
- Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30
- English proficiency
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (19 listed)
- Condition impairing oral intake or digestive absorption.
- Primary brain tumor.
- Presence of delirium.
- Significant suicide risk as defined by suicidal ideation with intent and a plan.
- Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history.
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-assisted PsychotherapyThe intervention will be psilocybin-assisted psychotherapy. The first treatment period will include four preparation sessions with Managing Cancer and Living Meaningfully (CALM) therapy elements. The psilocybin dosing session will take place after these preparation sessions are completed. The dosing session will include an in-person visit lasting approximately 8 hours in which the participant will receive a capsule of psilocybin 25 mg under constant supervision of therapists. The following day, the first integration session will take place and two weeks later the second integration session along with CALM will be conducted. Participants who show a partial response will be offered a second dosing session, entering the second treatment period. The second treatment period includes a second dosing session using the same dose and safety measures as the first one. It will also be followed by an integration session the following day, and a second integration session with CALM two weeks later. | Drug | advanced cancer participants |
Primary outcome
Demoralization Scale
Time frame: From enrollment to the end of the follow up period at week 16 or 19
Demoralization Scale is a 24-item Likert scale. Items are scored on a 5-point scale from 0 (never) to 4 (all the time), in which higher scores are associated with higher demoralization. Scores can range from 0 to 96. A cut-off point of ≥ 30 in this scale is considered as high demoralization and will be used for participant inclusion in the study.
Adverse Events (AEs) and Serious Adverse Events (SAEs) register
Time frame: From enrollment to the end of the follow up period at week 16 or 19
3 secondary outcomes
Hamilton Anxiety Rating Scale
Time frame: From enrollment to the end of the follow up period at week 16 or 19
Hamilton Depression Rating Scale
Time frame: From enrollment to the end of the follow up period at week 16 or 19
Columbia Suicide Severity Rating Scale
Time frame: From enrollment to the end of the follow up period at week 16 or 19
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 18 Mar 2026.
- 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.
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-assisted Psychotherapy in people with Demoralization and Safety, run by Gustavo Vazquez at 1 site in Canada.
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 6 inclusion and 19 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 18 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 Canada. 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 Gustavo Vazquez, MD, PhD, FRCPC (613-544-4900 x51214, vazquezg@providencecare.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demoralization Scale (time frame: From enrollment to the end of the follow up period at week 16 or 19). 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 18 Mar 2026.