Clinical Trial Details

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

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Trial Information

Broad Health Condition Mental Health
Mental Health
Cancer

Specific Health ConditionAnxiety
Depression
Any cancer

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Postcode
3065 - Fitzroy

Anticipated date of first participant enrolment27/09/2019

Anticipated date of last participant enrolment27/09/2019

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Trial summary

This trial aims to investigate the use of psilocybin (a psychedelic compound) in conjunction with psychotherapy for the treatment of anxiety and depression in terminally ill patients. 

Who is it for?
Adults aged between 18-85 years with a life threatening illness and currently under the care of a specialist physician are eligible for the study. Criteria for prospective participants includes psychological distress that was brought on by their life-threatening illness.

Study details
Participants will be rigorously screened, throughly prepared and supported throughout the treatment with two specialist clinicians present at all times throughout the treatment.  

Participants will be randomly allocated (50/50 chance) to either receive the active medication (Psilocybin 25mg) Arm 1 or a placebo (Niacin 100mg) in Arm 2. The medication or placebo will be taken once in the first arm of the study and have psychotherapy sessions with a health professional before, during and after the dose of medication/placebo. The next dose is 7 weeks later, where all participants will take the active drug, Psychotherapy sessions will take place before, during and after. All participants are followed for 26 weeks following the second dose and will be involved in interviews and questionnaires throughout the study period. 
 
Participants are followed up for 26 weeks after the second dose to ensure that we examine all changes that continue after treatment. Questionnaires and interviews are conducted throughout the study to fully understand the impact of the treatment and to monitor for safety.

It is hoped that this research could potentially offer a new treatment for terminally ill patients experiencing depression and anxiety, and hopes to alleviate psychological suffering at end of life.
Eligibility

Key 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.

Minimum age18 Years

Maximum age85 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key 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). 
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St. Vincent's Hospital Melbourne
Primary Sponsor Address: 41 Victoria Parade Fitzroy 3065 VIC
Primary Sponsor Country: Australia

Trial IDACTRN12619001225101

UTNU1111-1237-8914

Contact person for information and recruitmentMs
Virginia Francis
St. Vincent's Hospital Melbourne Psychosocial Cancer Care 41 Victoria Parade Fitzroy 3065 VIC
+61 3 9231 2211

Further information iconvirginia.francis@svha.org.au
Australia