Adjustment DisorderPhase 2NCT07072728
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
A Phase 2 study testing Psilocybin therapy in people with Adjustment Disorder and Adjustment Disorder With Anxious Mood, run by Psyence Australia Pty Ltd at 5 sites in Australia.
Trial summary
This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis. Who is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adjustment Disorder, Adjustment Disorder With Anxious Mood, Cancer
- What is being tested?
- Psilocybin therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 5 sitesAustralia
- Study dates
- 1 Oct 2025to 30 Dec 2027
- Phase
- Phase 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for study entry participants must satisfy all of the following criteria:
- Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer.
- Screening HAM-A Score ≥18 (moderate anxiety).
- Adults aged 18 to 80 years (inclusive) at screening.
- Diagnosed with cancer (exempting those cancers listed in the exclusion criteria) and a minimum life-expectancy of 6 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale performed at screening.
- Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10.
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- Able to communicate well and follow study procedures, judged as sufficiently competent with the English language by the investigator, able to build adequate rapport with study staff.
- Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist.
- Be medically suitable in the opinion of the investigator as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests.
- Have access to a device that is compatible to use the digital technology, i.e smart-phone device or tablet.
- Agree not to take any sedating medications for a minimum of 12 hours before the dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and zolpidem. Medications for cancer-related pain are permitted.
- Must be willing and able to refrain from smoking throughout the duration of the dosing session. Nicotine replacement therapies may be permitted with the agreement of the medical monitor.
- Agree that for 1 week before the psilocybin dosing session, participants will refrain from taking any illegal drugs or non-prescription medication (including cannabis, or CBD or THC containing products), nutritional supplement, or herbal supplement except when approved by the study investigators. Additionally, agree not to take any form of psilocybin outside of the study, including microdosing, from baseline through Day 70/Week 10 (Visit 11).
- Participants taking any other medication that is not explicitly detailed as an excluded medication will be discussed with the investigator and medical monitor as appropriate. Decisions on inclusion will be based on clinical judgement and with sufficient justification provided.
Who cannot join
- Participants will be excluded from the study if one or more of the following criteria are applicable:
- Psychiatric Exclusion Criteria:
- Current Major Depressive Disorder MDD (or within 12 months of Screening) deemed independent from the cancer diagnosis, current or past diagnosis of schizophrenia, psychotic disorder, unless this was resulting from a medical condition (e.g. lupus or malaria etc.), bipolar disorder I and II, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anti-social personality disorder or judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as determined using clinical judgement of past and present medical and psychiatric history by any specialist psychiatrist or registered medical professional under the authorized delegation of a specialist psychiatrist.
- First-degree relative with a diagnosed psychotic disorder.
- Scores from the screening psychiatrist (or registered medical professional under the authorized delegation of a specialist psychiatrist) and baseline (S-STS) that indicate that the participant is of clinically significant risk of suicide. A decision will be formed based on S-STS scores and used in combination with other clinically significant data at screening. Sites should refer to the medical monitor if required.
- Has attempted suicide in the twelve months preceding the screening visit.
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- Current (< 1 year) alcohol or drug misuse as identified as moderate or severe during screening in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, using the MINI 7.0.2, not able or willing to abstain from alcohol consumption in the period 12 hours prior to the dosing session.
- Any other reason that might prevent a participant from engaging in therapeutic preparation and integration sessions.
- Anyone who has taken a microdose of psilocybin within 5 days of baseline, taken a higher dose of psilocybin (e.g., dried mushrooms or capsules) within 30 days of baseline and experienced euphoria, hallucinations, or altered mental status, or used any classic psychedelics (LSD, ibogaine, ayahuasca, DMT, mescaline) within 3 months prior to baseline.
- Medical Exclusion Criteria:
- Diagnosed with brain metastases, glioblastoma, phaeochromocytoma, bowel obstruction or intestinal failure, active carcinoid syndrome, uncontrolled hypercalcaemia, or uncontrolled diabetes mellitus or insipidus.
- Currently taking or planning to take any of the following: any typical or atypical antipsychotic and monoamine-oxidase inhibitors. Participants with prior use of these medications must be willing to discontinue their use for at least 2 weeks prior to the baseline visit and to Day 28.
- Currently taking or planning to take any anticonvulsant or mood stabilizer, including carbamazepine, lithium, phenytoin, and valproate. Participants with prior use of these medications must be willing to discontinue their use for at least 1 week prior to the baseline visit and to Day 28.
- Any form of fungal allergy.
- Positive pregnancy test at screening, women who are breastfeeding or of childbearing potential who are unwilling or unable to use an effective form of contraception (or abstinence) for the study period and for 1 month post NPX-5 dose will be excluded. Women will be required to conduct a serum pregnancy test at the in-person screening visit and urine test prior to dosing session. Male participants who do not agree to use contraception for the study period and for 90 days post NPX-5 dose to mitigate the risk of pregnancy will also be excluded. Note: Refer to Section 4.3.2.1 for further details about contraception.
- A diagnosis of epilepsy or at significant risk of seizures based on medical history.
- Cardiovascular conditions including stroke and/or myocardial infarction (less than one year before providing informed consent), uncontrolled hypertension (blood pressure > 140/90 mmHg) or clinically significant arrhythmia at screening. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.
- Anyone who, at screening, has clinically significant findings on physical examination, including resting vital signs (HR below 40 or above 120 bpm, blood pressure below 90/60 or above 140/90), ECG (QTcF > 450 msec for males and >470 for females), and positive alcohol breath test. Note: Inclusion of individuals with any out-of-range values, including blood pressure, is at the discretion of the Investigator.
- Liver dysfunction at screening as defined by AST and/or ALT > 1.5 times the upper level of normal or upper reference range. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to the administration of psilocybin, following discretion of the investigator.
- Renal Function: estimated glomerular filtration rate <60 mL/min (calculated using Chronic Kidney Disease Epidemiology Collaboration) unless this is a direct result of the cancer diagnosis and does not present a risk to the administration of psilocybin, following the discretion of the investigator.
- Any clinically significant laboratory abnormality(s) that in the opinion of the investigator would present a risk to the administration of psilocybin.
- Any clinically significant renal, pulmonary, gastrointestinal, hepatic, or other illness that could affect the interpretation of results or be a potential health risk for the person if they were to be included in the study. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.
- Below 18 or above 32kg/m2 Body Mass Index (BMI) score at Screening.
- Anyone with organic brain injury or diagnosed with any cognitive impairment.
- Positive urine drug test for non-prescribed psychoactive substances at the dosing session visit. Positive urine drug test for psychoactive substances at the in-person screening should be referred to the medical monitor. Note: Testing may be repeated once at the discretion of the Investigator.
- Anyone on a research study of an investigational drug or who has been on a clinical trial within 3 months of enrolment.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Recruiting
Mind Medicine Australia Clinic
Abbotsford, Victoria, 3067
Kayla Karaitiana, +61 03 9828 7566, kaylakaraitiana@mindmedclinic.com.au
Kevin Ong
- Recruiting
Empax Centre
Leederville, Western Australia, 6007
Claudia Sullivan, +61 403 768 280, csullivan@emyria.com
Jonathan Laugharne
- Recruiting
Neurocentrix
Melbourne, Victoria, 3053
Dami Rozakis, +61 3 9546 0009, demi@neurocentrix.com.au
David Barton
- Recruiting
Ramsay Northside Clinic
Melbourne, Victoria, 3053
Vanessa Dennis, DennisV@ramsayhealth.com.au
Justin Ellis
- Recruiting
Paratus Clinical Research Melbourne
Northcote, Victoria, 3070
Bernadette Fitzgibbon, +61 1300 742 326, bernadette.fitzgibbon@paratusclinical.com
Paul Fitzgerald
About this study
Official title: A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.
This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.
Who is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder.
Read more
Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day).
At Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5.
It is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.
Read the detailed description
This is a randomized, double-blind, low-dose comparator-controlled Phase IIb study to investigate the efficacy and safety of PAP with 25 mg, 10 mg and 1 mg [low-dose comparator) NPX-5, for the treatment of adjustment disorder symptoms in participants diagnosed with cancer. The referring oncologist will indicate that the participant is physically capable of undergoing psychedelic encounter and is likely to have a minimum life expectancy of 6 months.
At least 87 adult participants (age 18 to 80 at screening) with a diagnosis of AjD due to cancer diagnosis will be enrolled in this study. Participants will be randomly assigned with a ratio of 1:1:1 to receive Psilocybin-Assisted Psychotherapy (PAP) with either 25 mg, 10 mg or 1 mg NPX-5. Both the site staff treating participants and the participants themselves will be blinded to the treatments being administered.
The study consists of a combination of clinic visits and telehealth phone calls to support this vulnerable participant population. The clinic will have experience with conducting PAP. All study visits be carried out by suitably qualified individuals and wherever possible, the same therapist will meet with study participants for in-person and telehealth appointments. Participants will undertake a screening visit between Day -45 and Day -2 to determine eligibility to participate in the study. Those participants that meet the eligibility criteria will attend the study site on Day 1 when continued eligibility will be assessed and baseline assessments performed.
Participants must complete three preparation sessions with the therapist prior to dosing session. Two of these sessions can be completed remotely via telehealth and have flexible timing, provided there is at least one day between each session. One preparation session must be done in person in the dosing room, ideally during a site visit on Day 13. Additionally, at least one preparation session must include the sitter or secondary therapist. The primary therapist has the discretion to include the sitter or secondary therapist in more preparation or integration sessions based on their assessment.
The clinic site visits will comprise Day 1, Day 13 (day prior dosing session), Day 14 (dosing session), Day 15 (integration session) and Day 70/Week 10 (follow-up) post-randomization. There will be ± 3 days for a dosing session allowed. Subsequently, all relevant visits will be adjusted accordingly. In addition, participants will be required to attend following telehealth appointments:
- Two telehealth appointments for preparatory sessions within 2 weeks prior to dosing session.
- One telehealth appointment for integration therapy session in the two weeks following the dosing session.
- Follow up telehealth appointments on Day 28 (Week 4), Day 42 (Week 6).
- Final study follow-up telehealth appointment at 3 months post the Day 70 (Week 10) visit of the final PAP cycle for final safety assessments.
Non responders (for criteria see Section 5.5.2) at Day 70 (Week 10) that continue to meet the study eligibility criteria, may commence an additional PAP cycle (at 25 mg NPX-5). These participants will repeat the schedule described above, including the visit the day prior to dosing session, the actual dosing session, and the integration sessions. A maximum of 2 PAP cycles may be administered.
- Conditions
- Adjustment Disorder, Adjustment Disorder With Anxious Mood, Cancer, Cancer Cachexia, Cancer of Endometrium, Cancer of Kidney
- Being tested
- Psilocybin therapy
- Keywords
- Cancer, Adjustment Disorder, Existential Distress, Psilocybin, Psilocin
- Medical subject headings
- Adjustment Disorders, Neoplasms, Endometrial Neoplasms, Kidney Neoplasms, Prostatic Neoplasms, Breast Neoplasms, Stomach Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin therapyDrug
Following a screening period, eligible participants will undergo one cycle of psilocybin-assisted psychotherapy (PAP). Non-responders at Week 10 who continue to meet eligibility criteria will be offered a second PAP cycle at the 25 mg NPX-5 dose. A maximum of two PAP cycles may be given. Long-term follow-up will include a visit at Month 3 following the final PAP cycle.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 25 mg NPX-5 Psilocybin Capsules | Active comparator | Participants in Group 1 will receive a single dose of 25 mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the same 25 mg dose. A maximum of two PAP cycles may be administered. Receives: Drug: Psilocybin therapy |
| Group 2: 10 mg NPX-5 Psilocybin Capsules | Active comparator | Participants in Group 2 will receive a single dose of 10mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the 25 mg dose. A maximum of two PAP cycles may be administered. Receives: Drug: Psilocybin therapy |
| Group 3: 1 mg NPX-5 (low-dose comparator) | Placebo comparator | Participants in Group 3 will receive a single dose of 1mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the same 25 mg dose. A maximum of two PAP cycles may be administered. Receives: Drug: Psilocybin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Severity
To assess the change in anxiety severity in participants with Adjustment Disorder (AjD) due to a cancer diagnosis, as measured by the Hamilton Anxiety Rating Scale (HAM-A). The Hamilton Anxiety Rating Scale (HAM-A) ranges from 0 to 56, with higher scores indicating greater anxiety severity.
Measured: Comparison between treatment groups in the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score at Week 10 after a single PAP cycle.
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0
To assess the safety and tolerability of a single dose of NPX-5 (25 mg, 10 mg and 1 mg [low-dose comparator]) in people with AjD with a cancer diagnosis.
Measured: Assessment of Day 14 (dosing day) vital signs (pre-dose and prior to discharge).
Safety and Tolerability of a Single Dose of NPX-5 using the Sheehan Suicide Tracking Scale (S-STS)
To assess the safety and tolerability of a single dose of NPX-5 (25 mg, 10 mg, and 1 mg [low-dose comparator]) in people with Adjustment Disorder (AjD) due to a cancer diagnosis, using the Sheehan Suicide Tracking Scale (S-STS). The Sheehan Suicide Tracking Scale (S-STS) is a clinician-rated measure of suicidality that assesses suicidal ideation and behaviour. The scale consists of 14 items, with scores ranging from 0 to 60, where higher scores indicate greater suicidality risk.
Measured: Assessment of suicidality using the Sheehan Suicide Tracking Scale (S-STS) at baseline, Day 13, Day 15, Weeks 4, 6, and 10, and 3 months post-final cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Oct 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjustment DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants will be centrally randomized 1:1:1 to a treatment group. * Group 1: 25 mg NPX-5; * Group 2: 10 mg NPX-5; * Group 3: 1 mg NPX-5(low-dose comparator).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psyence Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Maresky, Study director, Psyence Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072728
- Sponsor's protocol ID
- PSY-01
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study-level documents, such as the Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and Analytic Code, may not be shared at this time due to proprietary and confidential information. These documents contain data or methodologies that are critical to the sponsor's intellectual property and the integrity of ongoing or future analyses.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.
- ClinicalTrials.gov ID
- NCT07072728
- Acronym / sponsor ID
- PSY-01
- Conditions
- Adjustment Disorder, Adjustment Disorder With Anxious Mood, Cancer, Cancer Cachexia, Cancer of Endometrium, Cancer of Kidney
- Keywords
- Cancer, Adjustment Disorder, Existential Distress, Psilocybin, Psilocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Psyence Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Jul 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.
This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.
Who is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder.
Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day).
At Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5.
It is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.
Detailed description
This is a randomized, double-blind, low-dose comparator-controlled Phase IIb study to investigate the efficacy and safety of PAP with 25 mg, 10 mg and 1 mg [low-dose comparator) NPX-5, for the treatment of adjustment disorder symptoms in participants diagnosed with cancer. The referring oncologist will indicate that the participant is physically capable of undergoing psychedelic encounter and is likely to have a minimum life expectancy of 6 months.
At least 87 adult participants (age 18 to 80 at screening) with a diagnosis of AjD due to cancer diagnosis will be enrolled in this study. Participants will be randomly assigned with a ratio of 1:1:1 to receive Psilocybin-Assisted Psychotherapy (PAP) with either 25 mg, 10 mg or 1 mg NPX-5. Both the site staff treating participants and the participants themselves will be blinded to the treatments being administered.
The study consists of a combination of clinic visits and telehealth phone calls to support this vulnerable participant population. The clinic will have experience with conducting PAP. All study visits be carried out by suitably qualified individuals and wherever possible, the same therapist will meet with study participants for in-person and telehealth appointments. Participants will undertake a screening visit between Day -45 and Day -2 to determine eligibility to participate in the study. Those participants that meet the eligibility criteria will attend the study site on Day 1 when continued eligibility will be assessed and baseline assessments performed.
Participants must complete three preparation sessions with the therapist prior to dosing session. Two of these sessions can be completed remotely via telehealth and have flexible timing, provided there is at least one day between each session. One preparation session must be done in person in the dosing room, ideally during a site visit on Day 13. Additionally, at least one preparation session must include the sitter or secondary therapist. The primary therapist has the discretion to include the sitter or secondary therapist in more preparation or integration sessions based on their assessment.
The clinic site visits will comprise Day 1, Day 13 (day prior dosing session), Day 14 (dosing session), Day 15 (integration session) and Day 70/Week 10 (follow-up) post-randomization. There will be ± 3 days for a dosing session allowed. Subsequently, all relevant visits will be adjusted accordingly. In addition, participants will be required to attend following telehealth appointments:
- Two telehealth appointments for preparatory sessions within 2 weeks prior to dosing session.
- One telehealth appointment for integration therapy session in the two weeks following the dosing session.
- Follow up telehealth appointments on Day 28 (Week 4), Day 42 (Week 6).
- Final study follow-up telehealth appointment at 3 months post the Day 70 (Week 10) visit of the final PAP cycle for final safety assessments.
Non responders (for criteria see Section 5.5.2) at Day 70 (Week 10) that continue to meet the study eligibility criteria, may commence an additional PAP cycle (at 25 mg NPX-5). These participants will repeat the schedule described above, including the visit the day prior to dosing session, the actual dosing session, and the integration sessions. A maximum of 2 PAP cycles may be administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be centrally randomized 1:1:1 to a treatment group. * Group 1: 25 mg NPX-5; * Group 2: 10 mg NPX-5; * Group 3: 1 mg NPX-5(low-dose comparator).
| Arm | Type | Receives |
|---|---|---|
| Group 1: 25 mg NPX-5 Psilocybin Capsules | Active comparator | Drug: Psilocybin therapyParticipants in Group 1 will receive a single dose of 25 mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the same 25 mg dose. A maximum of two PAP cycles may be administered. |
| Group 2: 10 mg NPX-5 Psilocybin Capsules | Active comparator | Drug: Psilocybin therapyParticipants in Group 2 will receive a single dose of 10mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the 25 mg dose. A maximum of two PAP cycles may be administered. |
| Group 3: 1 mg NPX-5 (low-dose comparator) | Placebo comparator | Drug: Psilocybin therapyParticipants in Group 3 will receive a single dose of 1mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the same 25 mg dose. A maximum of two PAP cycles may be administered. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer.
- Screening HAM-A Score ≥18 (moderate anxiety).
- Adults aged 18 to 80 years (inclusive) at screening.
- Diagnosed with cancer (exempting those cancers listed in the exclusion criteria) and a minimum life-expectancy of 6 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale performed at screening.
- Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10.
Key exclusion criteria (26 listed)
- Participants will be excluded from the study if one or more of the following criteria are applicable:
- Current Major Depressive Disorder MDD (or within 12 months of Screening) deemed independent from the cancer diagnosis, current or past diagnosis of schizophrenia, psychotic disorder, unless this was resulting from a medical condition (e.g. lupus or malaria etc.), bipolar disorder I and II, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anti-social personality disorder or judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as determined using clinical judgement of past and present medical and psychiatric history by any specialist psychiatrist or registered medical professional under the authorized delegation of a specialist psychiatrist.
- First-degree relative with a diagnosed psychotic disorder.
- Scores from the screening psychiatrist (or registered medical professional under the authorized delegation of a specialist psychiatrist) and baseline (S-STS) that indicate that the participant is of clinically significant risk of suicide. A decision will be formed based on S-STS scores and used in combination with other clinically significant data at screening. Sites should refer to the medical monitor if required.
- Has attempted suicide in the twelve months preceding the screening visit.
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 therapyFollowing a screening period, eligible participants will undergo one cycle of psilocybin-assisted psychotherapy (PAP). Non-responders at Week 10 who continue to meet eligibility criteria will be offered a second PAP cycle at the 25 mg NPX-5 dose. A maximum of two PAP cycles may be given. Long-term follow-up will include a visit at Month 3 following the final PAP cycle. | Drug | Group 1: 25 mg NPX-5 Psilocybin Capsules, Group 2: 10 mg NPX-5 Psilocybin Capsules, Group 3: 1 mg NPX-5 (low-dose comparator) |
Primary outcome
Anxiety Severity
Time frame: Comparison between treatment groups in the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score at Week 10 after a single PAP cycle.
To assess the change in anxiety severity in participants with Adjustment Disorder (AjD) due to a cancer diagnosis, as measured by the Hamilton Anxiety Rating Scale (HAM-A). The Hamilton Anxiety Rating Scale (HAM-A) ranges from 0 to 56, with higher scores indicating greater anxiety severity.
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0
Time frame: Assessment of Day 14 (dosing day) vital signs (pre-dose and prior to discharge).
To assess the safety and tolerability of a single dose of NPX-5 (25 mg, 10 mg and 1 mg [low-dose comparator]) in people with AjD with a cancer diagnosis.
Safety and Tolerability of a Single Dose of NPX-5 using the Sheehan Suicide Tracking Scale (S-STS)
Time frame: Assessment of suicidality using the Sheehan Suicide Tracking Scale (S-STS) at baseline, Day 13, Day 15, Weeks 4, 6, and 10, and 3 months post-final cycle.
To assess the safety and tolerability of a single dose of NPX-5 (25 mg, 10 mg, and 1 mg [low-dose comparator]) in people with Adjustment Disorder (AjD) due to a cancer diagnosis, using the Sheehan Suicide Tracking Scale (S-STS). The Sheehan Suicide Tracking Scale (S-STS) is a clinician-rated measure of suicidality that assesses suicidal ideation and behaviour. The scale consists of 14 items, with scores ranging from 0 to 60, where higher scores indicate greater suicidality risk.
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 29 Oct 2026.
- Individual participant dataSharing planned: No. Study-level documents, such as the Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and Analytic Code, may not be shared at this time due to proprietary and confidential information. These documents contain data or methodologies that are critical to the sponsor's intellectual property and the integrity of ongoing or future analyses.
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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.
Neil Maresky study director
Psyence Biomedical
5 sites 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 therapy in people with Adjustment Disorder and Adjustment Disorder With Anxious Mood, run by Psyence Australia Pty Ltd at 5 sites in Australia.
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 14 inclusion and 26 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 Tim Waugh (+61481354373, tim@psyencebiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Severity (time frame: Comparison between treatment groups in the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score at Week 10 after a single PAP cycle.). The study lists 3 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 29 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.