Does Psilocybin Require Psychedelic Effects to Treat Depression? (NCT05710237) | Clinical Trial Compass
CompletedPhase 2
Does Psilocybin Require Psychedelic Effects to Treat Depression?
Canada41 participantsStarted 2023-07-01
Plain-language summary
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of serotonin (5HT)2A receptor antagonists such as risperidone.
The purpose of this "double dummy" proof-of-concept trial is to evaluate whether psilocybin's antidepressant effects are dependent on its psychedelic effects. Sixty participants with treatment-resistant depression will be randomly assigned to one of three groups: 1) Psilocybin 25 mg plus risperidone 1 mg; 2) Psilocybin 25 mg plus placebo; and 3) Placebo plus risperidone 1 mg. The investigator's hypothesize that the combination of psilocybin and risperidone will be well tolerated, safe, and will block the psychedelic effects of psilocybin in patients diagnosed with treatment-resistant depression.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Outpatient adults 18 to 65 years old;
* Able to provide informed consent and read and communicate in English;
* Primary DSM-5 diagnosis of non-psychotic MDD, single or recurrent, based on the Structured Clinical Interview for DSM-5 (SCID-5);
* Diagnosis of treatment-resistant depression defined as a baseline HamD-17 score \> 14 and have not responded to two or more separate trials of antidepressants at an adequate dosage and duration (an antidepressant resistance rating score of three or more is considered an adequate trial) based on the Antidepressant Treatment History Form (ATHF); there is no upper limit on the number of treatment failures;
* Ability to take oral medication;
* All bloodwork within normal limits or assessed as not clinically significant by study physicians and an eGFR above 40mL/min/1.73m2;
* Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;
* Willing to and have tapered off current antidepressant and antipsychotic medications for a minimum of 2-weeks (or more depending on the medication) prior to baseline and for the duration of the study and whose physician confirms that it is safe for them to do so; AND
* Willing to and have tapered off current inhibitors of 5'-diphospho-glucuronosyltransferase (UGT)1A9 and 1A10, aldehyde dehydrogenase inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (AD…
What they're measuring
1
Feasibility of administering psilocybin (25mg) with risperidone (1mg)
Timeframe: 4 weeks
2
Tolerability and safety of administering psilocybin (25mg) with risperidone (1mg)