Psilocybin-assisted psychotherapy for the treatment of depression and anxiety associated with life-threatening illness

Phase 2

Completed

• Conditions: Depression in terminal illness (any palliative condition including malignant and non-malignant terminal illnesses); Anxiety in terminal illness (any palliative condition including malignant and non-malignan terminal illnesses); Mental Health - Anxiety; Mental Health - Depression; Cancer - Any cancer

• Registration Number: ACTRN12619001225101
• Lead Sponsor: St. Vincent's Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-05
• Study Completion: 2023-10-24
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Adults aged between 18-85 years with a life - threatening illness, under the care of a specialist physician; proficient in English (funds available for this research would preclude access to translators to enable non-English speaking participants); Experiencing psychological distress that was precipitate or augmented by their life-threatening illness; AKPS of 50 or above (or if participant is immobile but deemed physically well enough to participate by the study doctor and their treating physician, scores lower than 50; upon receipt of medial clearance from the potential participants primary treating physician and being screened by the study doctor and being deemed eligible.
Examples of eligible conditions include metastatic malignant diseases, end stage respiratory disease, end stage renal failure, incurable but indolent cancers that have a high likelihood of returning.

Exclusion Criteria

Diseases with major CNS involvement
Hepatic dysfunction
Known paraneoplastic syndrome or ectopic hormone production
Uncontrolled cardiovascular condtions, unstable angina, atrial fibrillation, TIA
Patients who are respirator dependent or intubated.
A diagnosis of epilepsy or known previous seizure activity
Renal insufficiency
Insulin dependent diabetes
Females who are pregnant, nursing, or attempting to become pregnant
Patients taking SSRI or SNRI (participant may be eligible if they would like to wean and cease under supervision and if deemed safe to do so)
Participants taking medications including:
Rifamycin, rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, paclitaxol, St John's Wort, - all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin.
PSYCHIATRIC - Severity of depression or anxiety symptoms that would warrant immediate hospitalisation (including acute suicidality); current or past history of psychosis/psychotic disorder, current or past history of bipolar disorder; first degree relative with psychosis or bipolar disorder; current or past history of alcohol or substance dependence (excluding caffeine or nicotine) in the past 5 years; Axis II conditions that may not e compatible with the treatment protocol (determined by clinical interview).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in depressive and anxiety symptoms as measured on the HADS [ Baseline, The day after Dose 1, 3 weeks post Dose 1, 7 weeks post dose 1 (1 day before dose 2)- PRIMARY TIMEPOINT, The day after Dose 2, 3 weeks post Dose 2, 7 weeks post Dose 2.];Changes in anxiety symptoms as measures on the STAI [ Baseline The day after Dose 1 3 weeks post Dose 1 7 weeks post dose 1 (1 day before dose 2), PRIMARY TIMEPOINT The day after Dose 2 3 weeks post Dose 2 7 weeks post Dose 2 (FOR SENSITIVITY ANALYSES)];Changes in depressive symptoms as measured on the BDI[ Baseline The day after Dose 1 3 weeks post Dose 1 7 weeks post dose 1 (1 day before dose 2), PRIMARY TIMEPOINT The day after Dose 2 3 weeks post Dose 2 7 weeks post Dose 2 (FOR SENSITIVITY ANALYSES)]