Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression (EPIsoDE)
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|ClinicalTrials.gov Identifier: NCT04670081|
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : July 29, 2021
The study aims to investigate the safety and efficacy of oral psilocybin administered under supportive conditions in treatment-resistant major depression (TRD).
The study is a bi-centric, prospective, randomized, active placebo-controlled study investigating the effects of 25 mg and 5 mg (p.o.) psilocybin versus placebo (100 mg nicotinamide) in a psychotherapeutic context in 144 patients with TRD from moderate to severe degree (ICD-10 F32/F33). After giving written informed consent and down-titration of their monoaminergic medication under supervision of the treating psychiatrist and the study team, patients will be randomly assigned to one of four trial arms using an online randomization tool: 1) receiving placebo (100 mg nicotinamide) at the first session and the full dose (25 mg) at the second; 2) receiving the presumably sub-effective dose (5 mg) at the first session and the full dose (25 mg) at the second; 3a) receiving the full dose (25 mg) at the first session and 5 mg at the second; 3b) receiving the full dose at both sessions. The two dosing sessions are accompanied by three preparatory and four integration sessions.
Drug administration must occur under psychotherapeutic conditions. Two trained therapists (one male, one female) will be assigned to each patient and be present during each dosing, preparatory and integration sessions. We will follow the safety guidelines provided by Johnson et al. (2), including a thorough preparation, establishment of trust/rapport, a safe and pleasing physical environment and sufficient interpersonal support. For safety reasons and close monitoring, patients will stay hospitalized for one night after each dosing session (i.e. in-patient setting).
|Condition or disease||Intervention/treatment||Phase|
|Treatment-resistant Depression||Drug: Psilocybin Drug: Nicotinamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||A Phase II Randomized, Double-blind, Active Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of Psilocybin in Treatment-resistant Major Depression|
|Actual Study Start Date :||June 10, 2021|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||March 1, 2024|
Placebo Comparator: Nicotinamide
1st dose: 100 mg Nicotinamide (Vitamin B3) - 2nd dose (after 6 weeks/after assessment of the primary endpoint): 25 mg Psilocybin
25 mg, p.o.
100 mg, p.o.
Experimental: Psilocybin (low-dose)
1st dose: 5 mg Psilocybin - 2nd dose (after 6 weeks/after assessment of the primary endpoint): 25 mg Psilocybin
25 mg, p.o.
5 mg, p.o.
Experimental: Psilocybin (high-dose)
25 mg, p.o.
5 mg, p.o.
- Treatment Response (defined as a ≥ 50% drop in depressive symptom severity as measured by the Hamilton Rating Scale for Depression; HAM-D) [ Time Frame: Baseline - 6 weeks after the first dose ]The HAM-D is a 21-item rating scale to assess the severity of depressive symptoms after a semi-structured clinical interview. Items are rated on a scale from 0 (absent) to 4. The total score is calculated by summing the first 17 items (HAM-D17) and ranges between 0 and 51.
- % change in HAM-D total score [ Time Frame: Baseline - 1 day/1 week/6 weeks after the first dose ]
- Treatment Response (defined as a ≥ 50% drop in depressive symptom severity as measured by the Hamilton Rating Scale for Depression; HAM-D) [ Time Frame: Baseline - 1 day/1 week after the first dose ]
- Treatment response (≥ 50% drop) and % change in HAM-D total score [ Time Frame: Baseline - 12 weeks after the first dose ]
- Treatment response (≥ 50% drop) and % change in the Beck Depression Inventory (BDI) - II [ Time Frame: Baseline - 1 day/1 week/6 weeks after both doses ]The BDI is a reliable and valid 21-item self-rating questionnaire for the assessment of depressive symptoms. Patients rate their symptoms according to four severity ratings per item (0-3). The total score determines the severity of depression, differentiating between absent (0 - 9), mild (10 - 18), moderate (19 - 29) and severe (≥ 30) depression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04670081
|Contact: Gerhard Gründer, Prof. Dr.||+49 621 1703 email@example.com|
|Contact: Lea Mertens, M. Sc.||+49 621 1703 firstname.lastname@example.org|
|Charité Berlin, Campus Mitte, Department of Psychiatry and Psychotherapy||Recruiting|
|Berlin, Germany, 10117|
|Contact: Andreas Ströhle, Prof. Dr. +49 30 450 517034 email@example.com|
|Contact: Michael Koslowski, Dr. firstname.lastname@example.org|
|Central Institute of Mental Health (CIMH)||Recruiting|
|Mannheim, Germany, 68159|
|Contact: Gerhard Gründer, Prof. Dr. +49 621 1703 1900 email@example.com|
|Contact: Lea Mertens, M. Sc. firstname.lastname@example.org|
|Principal Investigator:||Gerhard Gründer, Prof. Dr.||Central Institute of Mental Health, Mannheim|