Trial Outcomes & Findings for Frontline Clinician Psilocybin Study (NCT NCT05163496)

Last Updated: 2025-03-18

Results Overview

Assesses symptoms of depression (clinician-assessed): minimum score 0, max 60; higher score indicates more severe symptoms

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

4-weeks post psilocybin-assisted psychotherapy

Results posted on

2025-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Psilocybin Arm 2 preparation therapy sessions, then a medication session with 25mg psilocybin, then 3 integration therapy sessions. The psilocybin was provided by the Usona Institute.	Placebo 2 preparation therapy sessions, then a medication session with niacin 100 mg, then 3 integration therapy sessions. The niacin was provided by the Usona Institute.	Open-label Psilocybin (for Placebo Participants) 2 preparation therapy sessions, then a medication session with 25mg psilocybin, then 3 integration therapy sessions. The psilocybin was provided by the Usona Institute.
Randomized Phase STARTED	15	15	0
Randomized Phase COMPLETED	15	15	0
Randomized Phase NOT COMPLETED	0	0	0
Open Label Phase STARTED	0	0	12
Open Label Phase COMPLETED	0	0	12
Open Label Phase NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Frontline Clinician Psilocybin Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Psilocybin Arm n=15 Participants psychedelic assisted psychotherapy + 25mg psilocybin Psilocybin (Usona Institute): PAP + psilocybin 25 mg	Placebo n=15 Participants Psychedelic assisted psychotherapy + 250mg niacin Active placebo: PAP + niacin 250mg	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40 years n=5 Participants	36 years n=7 Participants	38 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4-weeks post psilocybin-assisted psychotherapy

Assesses symptoms of depression (clinician-assessed): minimum score 0, max 60; higher score indicates more severe symptoms

Outcome measures

Outcome measures
Measure	Psilocybin Arm n=15 Participants psychedelic assisted psychotherapy + 25mg psilocybin Psilocybin (Usona Institute): PAP + psilocybin 25 mg	Placebo n=15 Participants Psychedelic assisted psychotherapy + 250mg niacin Active placebo: PAP + niacin 250mg
Montgomery-Asberg Depression Rating Scale	21.33 score on a scale Standard Deviation 7.84	9.33 score on a scale Standard Deviation 7.32

SECONDARY outcome

Timeframe: 24 weeks post-psilocybin in the randomized phase psilocybin arm

Population: Participants in the placebo arm were not followed with the MADRS score after Day 28

Assesses symptoms of depression (clinician-assessed): minimum score 0, max 60; higher score indicates more severe symptoms

Outcome measures

Outcome measures
Measure	Psilocybin Arm n=15 Participants psychedelic assisted psychotherapy + 25mg psilocybin Psilocybin (Usona Institute): PAP + psilocybin 25 mg	Placebo Psychedelic assisted psychotherapy + 250mg niacin Active placebo: PAP + niacin 250mg
Montgomery-Asberg Depression Rating Scale	3.67 score on a scale Standard Deviation 4.48	—

SECONDARY outcome

Timeframe: 1,4,8,12,24 -weeks post psilocybin-assisted psychotherapy

Assesses professional burnout in 3 components that are scored separately (professional fulfillment, interpersonal disengagement, work exhaustion)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks post-psilocybin or placebo session

Assesses symptoms of post-traumatic stress disorder; minimum score 0, max 80; higher scores indicate more severe symptoms of PTSD

Outcome measures

Outcome measures
Measure	Psilocybin Arm n=15 Participants psychedelic assisted psychotherapy + 25mg psilocybin Psilocybin (Usona Institute): PAP + psilocybin 25 mg	Placebo n=15 Participants Psychedelic assisted psychotherapy + 250mg niacin Active placebo: PAP + niacin 250mg
PTSD Checklist for DSM-5 (PCL5)	16.67 score on a scale Standard Deviation 15.04	6.74 score on a scale Standard Deviation 10.69

SECONDARY outcome

Timeframe: 4, 24 weeks post-psilocybin-assisted psychotherapy

Assesses symptoms of moral injury: minimum score 10, max 100; higher score indicates more severe symptoms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 4, 8, 12, 24-weeks post-psilocybin-assisted psychotherapy

Assess self-reported symptoms of depression: minimum score 0, max 63; higher score indicates more severe symptoms of depression

Outcome measures

Outcome data not reported

Adverse Events

Psilocybin Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Open-label Psilocybin (for Placebo Participants)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony Back MD

University of Washington

Phone: 2066194367

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place