Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Psilocybin therapy · 1 trial · 11 indications
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Psilocybin therapy | DRUG | 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. |
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 ...
Psilocybin therapy is an investigational small molecule being studied for the treatment of Adjustment Disorder, including Adjustment Disorder with Anxious Mood, in cancer patients. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Psilocybin therapy targets the HTR2A receptor, acting as an agonist. This mechanism is the basis for its investigational use in treating Adjustment Disorder in cancer patients, though the therapy remains in clinical development and its effects are still being evaluated.
Psilocybin therapy is being developed by Psyence Biomedical Ltd., a biopharmaceutical company. The company is conducting clinical trials to evaluate the therapy's safety and efficacy in patients with Adjustment Disorder related to cancer.
Psilocybin therapy is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to assess its safety and effectiveness for Adjustment Disorder in cancer patients.
Psilocybin therapy is being studied in a Phase 2 clinical trial with the identifier NCT07072728, titled 'Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder.' This randomized, double-blind, placebo-controlled trial is recruiting 87 participants in Australia.
Psilocybin therapy refers to the investigational use of psilocybin, a naturally occurring psychedelic compound, in a therapeutic setting. In this context, it is being developed by Psyence Biomedical Ltd. for Adjustment Disorder in cancer patients, and is currently in Phase 2 trials.