"Psychedelic therapy is not highly effective for treatment resistant depression."
Evidence9
In the NEJM trial, sustained response at week 12 occurred in 20% of the 25 mg group, meaning most patients did not maintain response.
The randomized trial tracked sustained response through 12 weeks after dosing.
At week 12, sustained response was reported for 20% of the 25 mg group, indicating that most participants did not maintain response over that period.
The randomized trial tracked sustained response through 12 weeks after dosing.
At week 12, sustained response was reported for 20% of the 25 mg group, indicating that most participants did not maintain response over that period.
The NEJM trial's week-3 response rate was 37% in the 25 mg group, leaving most participants without response.
In the 25 mg group, response at week 3 was reported for 37% of participants.
That means the majority of participants did not meet the response threshold, which is inconsistent with a highly effective treatment for everyone in the sample.
In the 25 mg group, response at week 3 was reported for 37% of participants.
That means the majority of participants did not meet the response threshold, which is inconsistent with a highly effective treatment for everyone in the sample.
Remission at week 3 was 29% in the 25 mg group, so most participants were not in remission.
The trial defined remission using a low clinician-rated depression score at week 3.
Only 29% of participants in the 25 mg group met remission, meaning most were not in remission at the primary time point.
The trial defined remission using a low clinician-rated depression score at week 3.
Only 29% of participants in the 25 mg group met remission, meaning most were not in remission at the primary time point.
Adverse events were reported by 84% of patients in the 25 mg group, and 9% had severe adverse events between day 2 and week 3.
Safety reporting in the randomized trial recorded adverse events and severe adverse events by period.
In the 25 mg group, 84% reported adverse events, and 9% had severe adverse events between day 2 and week 3, indicating notable short-term side effects.
Safety reporting in the randomized trial recorded adverse events and severe adverse events by period.
In the 25 mg group, 84% reported adverse events, and 9% had severe adverse events between day 2 and week 3, indicating notable short-term side effects.
Serious adverse events in the 25 mg and 10 mg groups included suicidal ideation and intentional self-injury.
The trial reported serious adverse events from day 2 to week 3 in the psilocybin groups.
These serious events included suicidal ideation and intentional self-injury in the 25 mg and 10 mg groups, indicating safety concerns for some participants.
The trial reported serious adverse events from day 2 to week 3 in the psilocybin groups.
These serious events included suicidal ideation and intentional self-injury in the 25 mg and 10 mg groups, indicating safety concerns for some participants.
In the 20-patient open-label study, only 4 participants were in remission at week 5.
The six-month follow-up study tracked remission after two psilocybin sessions.
Only 4 of 20 participants met remission criteria at week 5, meaning most were not in remission even in this open-label setting.
The six-month follow-up study tracked remission after two psilocybin sessions.
Only 4 of 20 participants met remission criteria at week 5, meaning most were not in remission even in this open-label setting.
In the 19-patient adjunct antidepressant study, 42% met response/remission at week 3, so most did not.
This open-label study tested psilocybin while participants continued selective serotonin reuptake inhibitor antidepressant treatment.
At week 3, 42% met response and remission criteria, meaning most participants did not reach those thresholds.
This open-label study tested psilocybin while participants continued selective serotonin reuptake inhibitor antidepressant treatment.
At week 3, 42% met response and remission criteria, meaning most participants did not reach those thresholds.
In the 7-patient pilot, only 3 of 7 met response/remission at the primary endpoint, and the rest did not.
The pilot trial reported outcomes for seven completers at the 3-week primary endpoint.
Only 3 of 7 met response and remission criteria, while the remaining participants did not, indicating mixed outcomes in this small sample.
The pilot trial reported outcomes for seven completers at the 3-week primary endpoint.
Only 3 of 7 met response and remission criteria, while the remaining participants did not, indicating mixed outcomes in this small sample.
In the NEJM trial, the 10 mg dose had response and remission rates similar to the 1 mg control (19% vs 18% response; 9% vs 8% remission).
The randomized trial compared 25 mg, 10 mg, and 1 mg doses.
At week 3, the 10 mg group had response and remission rates nearly identical to the 1 mg control group (19% vs 18% response; 9% vs 8% remission), showing limited benefit at the lower dose.
The randomized trial compared 25 mg, 10 mg, and 1 mg doses.
At week 3, the 10 mg group had response and remission rates nearly identical to the 1 mg control group (19% vs 18% response; 9% vs 8% remission), showing limited benefit at the lower dose.