Treatment Resistant Depression Intervention with Psilocybin-assisted Psychotherapy
- Conditions
- Treatment Resistant DepressionMental Health - Depression
- Registration Number
- ACTRN12623000832673
- Lead Sponsor
- St. Vincent's Hospital, Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
· Male and female participants 18 - 75 years of age.
· Have given written informed consent.
· Currently under the care of a psychiatrist who is able to provide a referral and willing to maintain ongoing oversight of their patient’s clinical care and treatment management throughout the duration of the study.
· Have a DSM-5 diagnosis of Major Depressive Disorder and currently experiencing a major depressive episode, as confirmed by the study psychiatrist.
· Failed to clinically respond to two different classes of antidepressant medication treatment (despite adequate dose compliance and minimum treatment duration of 6 weeks) during the current major depressive episode.
· Have baseline MADRS score greater than or equal to 20.
· Able to maintain stable psychotropic medications (including stable dose) from time of first psilocybin dose to last psilocybin dose, and at a dose not exceeding the recommended upper dose limit according to the Australian Medicines Handbook.
· Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 4 weeks prior to screening and is expected to remain stable until the final dose of psilocybin.
· Will have accompanied transport home after treatment sessions and availability of a friend or family member and home-like environment for the 24 hours following psilocybin dosing.
· Able to engage with psychotherapy.
· Able to be followed up for entire duration of the study (i.e., planning to remain in Sydney for the duration of the study).
· In good general medical health as confirmed by study doctor assessment supported with information from GP/referring psychiatrist.
· Agree to refrain from using any alcoholic beverages or nicotine, within 24 hours of each drug administration. The exception is caffeine.
· Agree to only take medications on the mornings of drug sessions that have been approved by the study psychiatrist.
· Agree to refrain from taking any non-prescription drugs, nutritional supplements, or herbal supplements for one week before each psilocybin administration unless approved by the study psychiatrist.
· Have none or limited lifetime use of hallucinogens (none in last 12 months).
· Worked or studied in a context requiring some proficiency in spoken English (to ensure validity of neuropsychological testing).
· Adequate clinical, ongoing support from own treating psychiatrist and other mental health clinicians, including safety plan in the event of becoming acutely suicidal, as determined by the study psychiatrist.
· Women who are pregnant, intend to become pregnant during the study or who are currently nursing.
· Have any significant cardiovascular conditions including uncontrolled hypertension.
· Have epilepsy or a history of seizures.
· Have history of any substance use disorder (except nicotine or caffeine) within the past 12 months.
· Currently taking MAOIs, lithium or any other medication that may interfere with the study drug as determined by the study psychiatrist.
· Current or lifetime history of meeting DSM-5 criteria for any psychotic disorders (including mood disorders with psychotic features), or bipolar I or II disorder.
· Have a known first or second-degree relative with any psychotic disorder, or bipolar I or II disorder.
· Significant suicide risk within the past year, as judged by study psychiatrist and informed by C-SSRS.
· Have any condition preventing establishment of rapport and safe psilocybin treatment, as determined by the study psychiatrist.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of psilocybin-assisted psychotherapy in treatment resistant depression patients assessed by changes in heart rate, blood pressure, temperature, and monitoring of adverse events. Blood pressure and heart rate will be measured using an automatic blood pressure monitor, and temperature will be assessed using an aural thermometer. <br><br>Vital signs (i.e., blood pressure, heart rate and temperature) are measured at baseline, immediately prior to dosing then every 30min for the first two hours following dosing then hourly for 6 hours. Vital signs are measured at all dosing visits. Adverse events are assessed at every study visit according to clinical interview and examination. <br>[ 3 months post psilocybin dosing. ];Feasibility of psilocybin-assisted psychotherapy in treatment resistant depression patients by auditing study enrolment/withdrawal logs. [ 3 months post psilocybin dosing. ]
- Secondary Outcome Measures
Name Time Method Examine the effect of psilocybin-assisted psychotherapy on mood by Montgomery-Asberg Depression Rating Scale (MADRS); response defined as greater or equal to 50% decrease in MADRS score and remission defined as a MADRS score of less or equal to 10.[ 6 months post psilocybin dosing. ];The impact of psilocybin-assisted psychotherapy on quality of life as assessed by the Recovering Quality of Life (REQOL) scale.[ 6 months post psilocybin dosing. ];The impact of psilocybin-assisted psychotherapy on function will be assessed by WHO Disability Assessment Schedule (WHODAS). [ 6 months post psilocybin dosing. ];The impact of psilocybin-assisted psychotherapy on well-being as assessed using the Warwick Edinburgh Mental Well Being Scale (WEMWBS).[ 6 months post-psilocybin dosing]