A Phase 2b double-blind, randomized, low-dose... — Clinical Trial Details

Detailed Description

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.

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

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.

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A Phase 2b double-blind, randomized, low-dose comparator-controlled clinical trial to assess the efficacy and safety of PEX010 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to incurable cancer diagnosis

Detailed Description

Study Arms & Interventions

Experimental Arm

Interventions

Participants

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Inclusion Criteria

Exclusion Criteria

Study Details