A study of psilocybin-assisted psychotherapy for treatment-resistant depression (TRD)
An open-label study of the efficacy and feasibility of psilocybin-assisted psychotherapy for treatment-resistant depression (TRD)
Swinburne University of Technology
15 participants
Sep 30, 2022
Interventional
Conditions
Summary
This open-label trial will investigate feasibility and efficacy of psilocybin-assisted psychotherapy for treatment-resistant depression. Individuals will be thoroughly screened to ensure they meet all eligibility criteria before entering the trial. All participants will receive the trial treatment. The treatment consists of two psilocybin dosing sessions (second dose optional), preceded by 3 preparatory psychotherapy sessions and followed by 3 integrative psychotherapy sessions. Participants will be under the care of a specialist team of two psychotherapists throughout the intervention. Participants will undergo multiple assessment sessions throughout the trial and there will be a long-term follow up assessment 20 weeks after the second dose. Where possible, assessments will be conducted via online surveys. Some assessments need to take place at the study site; these will be at baseline, 1 day, 3 weeks, and 20 weeks after dose 2. Assessments include questionnaires, cognitive and social processing tasks, fMRI scans, blood samples, and semi-structured interviews. It is predicted that this treatment will be effective in reducing symptoms of depression in those with treatment resistant depression.
Eligibility
Inclusion Criteria6
- Adults experiencing treatment-resistant unipolar depression, under the care of a psychiatrist, psychologist, physician, or GP.
- Proficient in English.
- Currently living full-time in Victoria.
- Experiencing severe depression as diagnosed by a trial therapist, with use of a clinical interview and the Montgomery –Asberg Depression Rating Scale (MADRS).
- Experiencing depression that has not responded to two or more separate pharmacological interventions during the current depressive episode.
- Treating medical doctor can confirm patient has safely tapered and washed-out current antidepressant pharmacotherapy prior to baseline assessment.
Exclusion Criteria10
- Containdicated medical conditions including: cardiovascular conditions, major CNS disease, hepatic dysfunction, hypercalcaemia risk, epilepsy/seizures, renal insuffiency, diabetes, hypothyroidism.
- Females who are pregnant, breastfeeding, attempting to conceive or not using effective means of contraception
- Weight <40kg
- Taking a contraindicated medication that cannot be ceased for an appropriate length of time during the trial (may include opioids, metabolic inducers or inhibitors, drugs with a low therapeutic index, and antidepressant medications)
- MRI contraindications
- Any significant, uncorrected visual impairments. This is necessary as some of the cognitive and social processing tasks require visual inspection of stimuli.
- Extremely severe depression/anxiety/suicidality symptoms warranting immediate hospitalisation, as determined by the screening psychiatrist in a clinical interview.
- Current, past history or 1st degree relative with schizophrenia, psychotic disorder (unless induced by substance or medical condition), or Bipolar I/II, as determined by the screening psychiatrist in a clinical interview.
- Current or past (5 year) history of alcohol of substance use disorder (excluding caffeine and nicotine), as determined by the screening psychiatrist in a clinical interview and with the use of the DAST-10 and AUDIT.
- Current Dissociative disorder, Anorexia Nervosa, Bulimia Nervosa or other condition judged to be incompatible with establishment of rapport of safe psilocybin administration as determined by the screening psychiatrist.
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Interventions
Psilocybin-assisted psychotherapy The treatment being tested in this trial is psilocybin-assisted psychotherapy. This treatment includes both a drug and psychotherapy component. The drug component of the treatment consists of two 25 mg doses of psilocybin administered in the context of a psychotherapy session, called a 'dosing session'. There will also be 9 non-drug psychotherapy sessions. The total duration of the intervention will be 12 weeks. Dosing sessions During each dosing session, the participant will be administered 25mg of psilocybin (oral, capsule), under the supervision of a team of two therapists. Participants will be encouraged to focus on their internal experience and will be provided with eyeshades and headphones with a preselected playlist of music. Therapists will remain present throughout the session to provide occasional guidance and support, as necessary. These sessions are conducted at Swinburne University, Hawthorn campus, in a designated dosing room that has been furnished to create a relaxing, comfortable, living-room-like environment. Sessions will last approximately 6-8 hours. The two dosing sessions will be spaced 6 weeks apart, with the second session being optional. Non-drug psychotherapy sessions There will be a total of 9 non-drug psychotherapy session. Before the first dosing session there will be 3 preparatory psychotherapy (PP) sessions, spaced out across 3 weeks. Following each dosing session (regardless of whether participants opt-in to the second dose) there will be 3 integrative psychotherapy (IP) session (total of 6). IP 1 occurs day after dose 1, IP 2 occurs 7-14 days after dose 1, IP 3 occurs within 7 days prior to dose 2. IP 6 occurs day after dose 2, and IP 7 and IP 8 occur within 7-21 days after dose 2. PP sessions will focus on building a relationship between therapist and participant, discussing the common effects of the psilocybin, and teaching relevant skills such as anxiety management. IP sessions will focus on discussing the participant's experience during the dosing session and integrating any insights or changes in perspective into their daily life. All non-drug psychotherapy sessions will be 60-90 minutes and take place at either Swinburne University, Hawthorn campus or Millswyn Clinic in South Yarra. Therapists All psychotherapy sessions will be conducted by two trained therapists (psychiatrists, psychologists, psychotherapists), one of whom has medical training. All therapists have undergone specialist training in delivering this treatment, facilitated by experts in the field. Safety Participant heart rate and blood pressure will be monitored throughout the dosing session to ensure they remain within a safe range. Rescue medications (benzodiazepines) will also be on hand in the event of an adverse psychological reaction that does not respond to other therapeutic tactics. Adherence and Fidelity Intervention adherence will be monitored through attrition rates and opt-in rates for the second dose. Treatment fidelity will also be monitored. All dosing session will be video recorded and an independent expert will review excerpts and provide feedback to the psychotherapists where necessary.
Locations(1)
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ACTRN12621001097831