ACTRN12623000832673
Recruiting
Phase 1
Investigating the safety, feasibility and acceptability of psilocybin-assisted psychotherapy in treatment resistant depression.
St. Vincent's Hospital, Sydney0 sites20 target enrollmentAugust 3, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Treatment Resistant Depression
- Sponsor
- St. Vincent's Hospital, Sydney
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •· 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.
Exclusion Criteria
- •· 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.
Outcomes
Primary Outcomes
Not specified
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