None listed
Conditions
Brief summary
This study is assessing the efficacy and safety of PEX010 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to incurable cancer diagnosis Who is it for? You may be eligible to join this study if you are aged between 18 and 80 years old, and you suffer from anxiety after adjusting to an acutely stressful event of your cancer diagnosis. We call that an 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 PEX010 dose group, a 10 mg PEX010 dose group or a 1mg PEX010 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 PEX010 administered at Day 14 (dosing day). At Week 12, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg PEX010). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3- and 6-months post Week 12 (of the final cycle) to assess safety and tolerability of PEX010. 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.
Interventions
This Phase 2b study is a double-blind, 1:1:1 randomized, study to assess the efficacy, safety and tolerability of 25 mg, 10 mg and 1 mg [low-dose comparator] PEX010 in participants with adjustment disorder (AjD) following an incurable cancer diagnosis.
The study will consist of a combination of clinic visits and telehealth visits and will involve the following study sequence:
A screening visit (approximately 3 hours): within Day-28 to -1
Visit at the clinic for continued eligibility and baseli
This Phase 2b study is a double-blind, 1:1:1 randomized, study to assess the efficacy, safety and tolerability of 25 mg, 10 mg and 1 mg [low-dose comparator] PEX010 in participants with adjustment disorder (AjD) following an incurable cancer diagnosis. The study will consist of a combination of clinic visits and telehealth visits and will involve the following study sequence: A screening visit (approximately 3 hours): within Day-28 to -1 Visit at the clinic for continued eligibility and baseline assessments: Day -1 (1-2 hours) PAP cycle: Day 1 to Day 28 In Clinic Visits: Day 1, 13, 14, 15, 84 Telehealth appointments: Day 7, Day 21, Day 28, Day 56, Day 168 and Day 253 (Psychiatrist/Psychologist/Psychotherapist): Preparatory therapy session: Day 1, Day 7, Day 13 (approximately 1 hour) - Participants must complete three preparation sessions with the therapist in the two weeks prior to the dosing session. Two of these sessions can be completed remotely via telehealth and have flexible timing, The remote sessions can be conducted at any time between Day 1 and Day 13, 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 face to face appointment at Clinic on Day 13. Participants will attend three preparatory sessions (one virtual (Day 7) telehealth and two in-person (Day 1, Day 13)) in the two weeks prior to being treated with psilocybin. The therapist will support the participant to establish intentions and goals, to be prepared for a range of potential effects of the psilocybin and have sufficient information to approach the intervention with an open mind. Face to face appointment at clinic to be conducted with a suitably trained therapist (Psychiatrist/Psychologist/Psychotherapist). Drug administration: Day 14 (approximately 8 hours). Participants will receive a single administration of PEX010 (capsule) under medical supervision on Day 14. Participants will be supported through the acute effects of the psilocybin by a suitably qualified therapist who will be present throughout the drug-assisted session. For the majority of the session the participant will be encouraged to wear a headset with a playlist and a blindfold to encourage introspection. A mouth check will be conducted to ensure compliance with dosing. Integration Session: Integration sessions will be conducted on Day 15 and Day 21 (approximately 1 hour). The Integration session on Day 15 will be a Face-to-face appointment at clinic to be conducted with a suitably trained therapist (Psychiatrist/Psychologist/Psychotherapist). An integration session conducted via telehealth with a suitably trained therapist will be conducted remotely in the two weeks following the dosing session. The integration sessions allow participants to process the experience of their drug-assisted session, consolidate changes into their perspective, reinforce insights from the therapy, and revisit issues that arose during the session. During the integration sessions, the therapist will facilitate the participant to reflect on their experiences of the psilocybin intervention, with the aim of translating their experiences into practical and accessible objectives. Follow-up: Day 84 (week 12) (Clinic visit, approximately 1 hour) Eligible non-responders at Week 12 will be offered a second PAP cycle (at 25 mg PEX010 dose level). For eligible participants the second PAP cycle will include all activities from Day 13 onwards until Day 253. A maximum of 2 PAP cycles may be administered. To be conducted with a suitably trained therapist (Psychiatrist/Psychologist/Psychotherapist). Final study follow-up Follow-up Telehealth appointments (Approximately 1 hour): Day 168 (Month 3), Day 253 (Month 6) (calculated from the 12-week visit after the final PAP). To be conducted with a suitably trained therapist (Psychiatrist/Psychologist/Psychotherapist) Session attendance checklists will be incorporated throughout the duration of the study to ensure compliance with all components of the intervention.
Sponsors
Psyence Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for study entry participants must satisfy all of the following criteria: 1. Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score = 47.5 , a score of = 4 on the Distress Thermometer 2. Screening HAM-A Score =18 (moderate anxiety). 3. Adults aged 18 to 80 years (inclusive) at screening. 4. Diagnosed with incurable cancer (exempting those cancers listed in the exclusion criteria) and a minimum life-expectancy of 12 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale. 5. Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10. 6. 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. 7. Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist. 8. 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. 9. Have access to a device that is compatible to use the digital technology, i.e smart-phone device tablet. 10. Agree not to take any sedating medicationsfor a minimum of 12 hours before the dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and zolpidem. Medications for cancer-related pain are permitted. 11. 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. 12. Agree that for 1week 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. 13. 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
Exclusion criteria
Psychiatric Exclusion Criteria: 1. Current major depressive disorder (MDD) (or within 12 months of Screening), current or past diagnosis of schizophrenia, psychotic disorder, unless this was substance-induced or 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 assessed through medical history and the Mini Neuropsychiatric Inventory (MINI 7.0.2) by any specialist psychiatrist or registered medical professional under the authorized delegation of a specialist psychiatrist. 2. First-degree relative with a diagnosed psychotic disorder. 3. Scores from the screening psychiatrist (or registered medical professional under the authorized delegation of a specialist psychiatrist) and baseline (S-STS) indicate that the participant is of clinically significantrisk ofsuicide. 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. 4. Has attempted suicide in the 12 months preceding the screening visit. 5. Current (< 1 year) alcohol or drug abuse asidentified 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. 6. Any other reason that might prevent a participant from engaging in therapeutic preparation and integration sessions. 7. Previous use of psychedelics within 12 months preceding screening. Medical Exclusion Criteria: 1. Diagnosed with brain metastases, glioblastoma, phaeochromocytoma, bowel obstruction or intestinal failure, active carcinoid syndrome, uncontrolled hypercalcaemia, or uncontrolled diabetes mellitus or insipidus. 2. 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. 3. 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. 4. Participants who have taken selective serotonin reuptake inhibitor/serotoninnorepinephrine reuptake inhibitor (selective and norepinephrine reuptake inhibitor [SNRI] and selective serotonin reuptake inhibitor [SSRI]) within the last 3 months and/or who are planning to initiate them before Day 70 of their study participation. 5. Any form of fungal allergy. 6. 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 PEX010 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 PEX010 dose to mitigate the risk of pregnancy will also be excluded. Note: Refer to Section 5.3.2.1 for further details about contraception. 7. A diagnosis of epilepsy or at significant risk of seizures based on medical history. 8. 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. 9. Anyone who, at screening, has clinically significant findings on physical examination, including resting vital signs (heart rate 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: Testing for any outof-range values may be repeated at the discretion of the Investigator. 10. Liver dysfunction at screening as defined by ALT/AST >1.5 times the upper limit 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. 11. 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. 12. Any clinically significant laboratory abnormality(s) that in the opinion of the investigator would present a risk to the administration of psilocybin. 13. 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. 14. Below 18 or above 32 kg/m2 Body Mass Index (BMI) score at Screening. 15. Anyone with organic brain injury or diagnosed with any cognitive impairment. 16. Positive urine drug test for non-prescribed psychoactive substances at the Dosing sessionvisit. 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. 17. Anyone on a research study of an investigational drug or who has been on a clinical trial within 3 months of enrollment.
Outcome results
None listed