Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07072728 | Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder | PHASE2 | RECRUITING | 87 | — | — | Oct 1, 2025 | Jul 30, 2027 | Mar 3, 2026 | 3 | Australia |
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 ...