A study of psilocybin-assisted psychotherapy for treatment-resistant depression (TRD)

Phase 2

Recruiting

• Conditions: Treatment Resistant Depression (TRD); Mental Health - Depression

• Registration Number: ACTRN12621001097831
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-18
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Adults experiencing treatment-resistant unipolar depression, under the care of a psychiatrist, psychologist, physician, or GP.
2. Proficient in English.
3. Currently living full-time in Victoria.
4. Experiencing severe depression as diagnosed by a trial therapist, with use of a clinical interview and the Montgomery –Asberg Depression Rating Scale (MADRS).
5. Experiencing depression that has not responded to two or more separate pharmacological interventions during the current depressive episode.
6. Treating medical doctor can confirm patient has safely tapered and washed-out current antidepressant pharmacotherapy prior to baseline assessment.

Exclusion Criteria

1. Containdicated medical conditions including: cardiovascular conditions, major CNS disease, hepatic dysfunction, hypercalcaemia risk, epilepsy/seizures, renal insuffiency, diabetes, hypothyroidism.
2. Females who are pregnant, breastfeeding, attempting to conceive or not using effective means of contraception
3. Weight <40kg
4. 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)
5. MRI contraindications
6. Any significant, uncorrected visual impairments. This is necessary as some of the cognitive and social processing tasks require visual inspection of stimuli.
7. Extremely severe depression/anxiety/suicidality symptoms warranting immediate hospitalisation, as determined by the screening psychiatrist in a clinical interview.
8. 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.
9. 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.
10. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in depression, measured using the 16-item Quick Inventory of Depressive Symptomatology (QIDS) - self-rated. [Baseline, 1 day pre-, 1 day post-, and 3 weeks post- dose 1 and 2];Long-term change in depression, measured using the 16-item Quick Inventory of Depressive Symptomatology (QIDS) - self-rated. [Baseline and 20 weeks post-dose 2 <br>]