Clinical Trials Confirm the Efficacy of Psilocybin for Severe Depression
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Clinical Trials Confirm the Efficacy of Psilocybin for Severe Depression
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Clinical Trials Confirm the Efficacy of Psilocybin for Severe Depression.
In recent years, scientists have shown great interest in psilocybin, an extract from “magic mushrooms,” for its potential in treating depression and anorexia nervosa.
However, previous clinical trials had significant limitations, including small sample sizes, non-blinded trial designs, and inadequate adverse event assessments. Two recent clinical trials, although addressing some of these limitations to some extent, had relatively short follow-up periods of 2-3 weeks [1,2].
Therefore, a new clinical trial led by the Usona Institute was conducted, where a 25mg single-dose of psilocybin was administered alongside psychological support. The results revealed a quicker and more enduring antidepressant effect compared to a placebo over a 6-week follow-up period.
Montgomery-Åsberg Depression Rating Scale (MADRS) scores and Sheehan Disability Scale scores significantly decreased in the psilocybin group. These findings were published in the Journal of the American Medical Association [3].
![Clinical Trials Confirm the Efficacy of Psilocybin for Severe Depression
In recent years, scientists have shown great interest in psilocybin, an extract from "magic mushrooms," for its potential in treating depression and anorexia nervosa. However, previous clinical trials had significant limitations, including small sample sizes, non-blinded trial designs, and inadequate adverse event assessments. Two recent clinical trials, although addressing some of these limitations to some extent, had relatively short follow-up periods of 2-3 weeks [1,2].
Therefore, a new clinical trial led by the Usona Institute was conducted, where a 25mg single-dose of psilocybin was administered alongside psychological support. The results revealed a quicker and more enduring antidepressant effect compared to a placebo over a 6-week follow-up period. Montgomery-Åsberg Depression Rating Scale (MADRS) scores and Sheehan Disability Scale scores significantly decreased in the psilocybin group. These findings were published in the Journal of the American Medical Association [3].
Image
This randomized, double-blind, placebo-controlled phase 2 trial took place across 11 medical centers in the United States. Participants, aged 21-65, with severe depression lasting at least 60 days, and with a moderate or higher symptom severity level, were randomly assigned in a 1:1 ratio to receive a single dose of psilocybin or a niacin placebo, both with psychological support. Patients with a history of psychosis, bipolar disorder, substance use disorder, or current suicidal ideation were excluded.
A total of 104 participants were included in the intention-to-treat analysis, with 50 in the psilocybin group and 54 in the placebo group. At week 6, 1 participant in the psilocybin group and 9 in the placebo group dropped out or were lost to follow-up. Three participants in each group initiated antidepressant medication before the trial's end (day 43), with 2 in the psilocybin group and 1 in the placebo group also starting psychotherapy. No participants withdrew due to adverse events.
The psilocybin group demonstrated a significantly greater reduction in MADRS scores at day 43 compared to baseline (mean difference -12.3, p<0.001), as well as at day 8 (mean difference -12.0, p<0.001).
Image
Reduction in MADRS scores for the Psilocybin (yellow) and Placebo (blue) groups.
The psilocybin group had more participants with sustained treatment response (20/48 [42%] vs. 5/44 [11%], adjusted absolute difference 30.3, p=0.002). There was also a higher rate of sustained remission in the psilocybin group, but this difference did not reach statistical significance (12/48 [25%] vs. 4/44 [9.1%], adjusted absolute difference 15.9, p=0.05). The psilocybin group had a greater reduction in functional disability scores as assessed by the Sheehan Disability Scale (-2.31, p<0.001).
Psilocybin treatment was associated with improvements in various exploratory endpoints, including overall disease severity reduction, self-reported depressive and anxiety symptoms, and quality of life, but it had no effect on emotional blunting.
Both the psilocybin and placebo groups reported adverse events, with 44 (88%) and 33 (61%) participants, respectively, experiencing at least one adverse event. Within 9 days after dosing, 41 (82%) in the psilocybin group and 24 (44%) in the placebo group reported at least one drug-related adverse event, decreasing to 2 (4%) and 1 (2%) between days 10-43. There were no suicide or self-harm behaviors during the trial, and no clinically significant changes in vital signs or laboratory results were observed.
In summary, the results of this trial suggest that a 25mg single dose of psilocybin is more effective than placebo in improving depression symptoms with a high rate of sustained response and remission. Psilocybin was generally well-tolerated, with most adverse events being mild to moderate and typically limited to the acute dosing period.
Image
In a concurrent commentary, the authors point out that while psychedelic therapy may not be effective for every individual with depression, it represents a new approach to mental health treatment and a potential paradigm shift in disease management. Research into the mechanisms of action of psychedelic substances may also provide new insights into neuronal plasticity and brain function.](https://medicaltrend.org/wp-content/uploads/2023/09/230901mm11.webp)
This randomized, double-blind, placebo-controlled phase 2 trial took place across 11 medical centers in the United States.
Participants, aged 21-65, with severe depression lasting at least 60 days, and with a moderate or higher symptom severity level, were randomly assigned in a 1:1 ratio to receive a single dose of psilocybin or a niacin placebo, both with psychological support.
Patients with a history of psychosis, bipolar disorder, substance use disorder, or current suicidal ideation were excluded.
A total of 104 participants were included in the intention-to-treat analysis, with 50 in the psilocybin group and 54 in the placebo group. At week 6, 1 participant in the psilocybin group and 9 in the placebo group dropped out or were lost to follow-up.
Three participants in each group initiated antidepressant medication before the trial’s end (day 43), with 2 in the psilocybin group and 1 in the placebo group also starting psychotherapy. No participants withdrew due to adverse events.
The psilocybin group demonstrated a significantly greater reduction in MADRS scores at day 43 compared to baseline (mean difference -12.3, p<0.001), as well as at day 8 (mean difference -12.0, p<0.001).
![Clinical Trials Confirm the Efficacy of Psilocybin for Severe Depression
In recent years, scientists have shown great interest in psilocybin, an extract from "magic mushrooms," for its potential in treating depression and anorexia nervosa. However, previous clinical trials had significant limitations, including small sample sizes, non-blinded trial designs, and inadequate adverse event assessments. Two recent clinical trials, although addressing some of these limitations to some extent, had relatively short follow-up periods of 2-3 weeks [1,2].
Therefore, a new clinical trial led by the Usona Institute was conducted, where a 25mg single-dose of psilocybin was administered alongside psychological support. The results revealed a quicker and more enduring antidepressant effect compared to a placebo over a 6-week follow-up period. Montgomery-Åsberg Depression Rating Scale (MADRS) scores and Sheehan Disability Scale scores significantly decreased in the psilocybin group. These findings were published in the Journal of the American Medical Association [3].
Image
This randomized, double-blind, placebo-controlled phase 2 trial took place across 11 medical centers in the United States. Participants, aged 21-65, with severe depression lasting at least 60 days, and with a moderate or higher symptom severity level, were randomly assigned in a 1:1 ratio to receive a single dose of psilocybin or a niacin placebo, both with psychological support. Patients with a history of psychosis, bipolar disorder, substance use disorder, or current suicidal ideation were excluded.
A total of 104 participants were included in the intention-to-treat analysis, with 50 in the psilocybin group and 54 in the placebo group. At week 6, 1 participant in the psilocybin group and 9 in the placebo group dropped out or were lost to follow-up. Three participants in each group initiated antidepressant medication before the trial's end (day 43), with 2 in the psilocybin group and 1 in the placebo group also starting psychotherapy. No participants withdrew due to adverse events.
The psilocybin group demonstrated a significantly greater reduction in MADRS scores at day 43 compared to baseline (mean difference -12.3, p<0.001), as well as at day 8 (mean difference -12.0, p<0.001).
Image
Reduction in MADRS scores for the Psilocybin (yellow) and Placebo (blue) groups.
The psilocybin group had more participants with sustained treatment response (20/48 [42%] vs. 5/44 [11%], adjusted absolute difference 30.3, p=0.002). There was also a higher rate of sustained remission in the psilocybin group, but this difference did not reach statistical significance (12/48 [25%] vs. 4/44 [9.1%], adjusted absolute difference 15.9, p=0.05). The psilocybin group had a greater reduction in functional disability scores as assessed by the Sheehan Disability Scale (-2.31, p<0.001).
Psilocybin treatment was associated with improvements in various exploratory endpoints, including overall disease severity reduction, self-reported depressive and anxiety symptoms, and quality of life, but it had no effect on emotional blunting.
Both the psilocybin and placebo groups reported adverse events, with 44 (88%) and 33 (61%) participants, respectively, experiencing at least one adverse event. Within 9 days after dosing, 41 (82%) in the psilocybin group and 24 (44%) in the placebo group reported at least one drug-related adverse event, decreasing to 2 (4%) and 1 (2%) between days 10-43. There were no suicide or self-harm behaviors during the trial, and no clinically significant changes in vital signs or laboratory results were observed.
In summary, the results of this trial suggest that a 25mg single dose of psilocybin is more effective than placebo in improving depression symptoms with a high rate of sustained response and remission. Psilocybin was generally well-tolerated, with most adverse events being mild to moderate and typically limited to the acute dosing period.
Image
In a concurrent commentary, the authors point out that while psychedelic therapy may not be effective for every individual with depression, it represents a new approach to mental health treatment and a potential paradigm shift in disease management. Research into the mechanisms of action of psychedelic substances may also provide new insights into neuronal plasticity and brain function.](https://medicaltrend.org/wp-content/uploads/2023/09/230901mm22.webp)
Reduction in MADRS scores for the Psilocybin (yellow) and Placebo (blue) groups.
The psilocybin group had more participants with sustained treatment response (20/48 [42%] vs. 5/44 [11%], adjusted absolute difference 30.3, p=0.002).
There was also a higher rate of sustained remission in the psilocybin group, but this difference did not reach statistical significance (12/48 [25%] vs. 4/44 [9.1%], adjusted absolute difference 15.9, p=0.05).
The psilocybin group had a greater reduction in functional disability scores as assessed by the Sheehan Disability Scale (-2.31, p<0.001).
Psilocybin treatment was associated with improvements in various exploratory endpoints, including overall disease severity reduction, self-reported depressive and anxiety symptoms, and quality of life, but it had no effect on emotional blunting.
Both the psilocybin and placebo groups reported adverse events, with 44 (88%) and 33 (61%) participants, respectively, experiencing at least one adverse event.
Within 9 days after dosing, 41 (82%) in the psilocybin group and 24 (44%) in the placebo group reported at least one drug-related adverse event, decreasing to 2 (4%) and 1 (2%) between days 10-43.
There were no suicide or self-harm behaviors during the trial, and no clinically significant changes in vital signs or laboratory results were observed.
In summary, the results of this trial suggest that a 25mg single dose of psilocybin is more effective than placebo in improving depression symptoms with a high rate of sustained response and remission.
Psilocybin was generally well-tolerated, with most adverse events being mild to moderate and typically limited to the acute dosing period.
![Clinical Trials Confirm the Efficacy of Psilocybin for Severe Depression
In recent years, scientists have shown great interest in psilocybin, an extract from "magic mushrooms," for its potential in treating depression and anorexia nervosa. However, previous clinical trials had significant limitations, including small sample sizes, non-blinded trial designs, and inadequate adverse event assessments. Two recent clinical trials, although addressing some of these limitations to some extent, had relatively short follow-up periods of 2-3 weeks [1,2].
Therefore, a new clinical trial led by the Usona Institute was conducted, where a 25mg single-dose of psilocybin was administered alongside psychological support. The results revealed a quicker and more enduring antidepressant effect compared to a placebo over a 6-week follow-up period. Montgomery-Åsberg Depression Rating Scale (MADRS) scores and Sheehan Disability Scale scores significantly decreased in the psilocybin group. These findings were published in the Journal of the American Medical Association [3].
Image
This randomized, double-blind, placebo-controlled phase 2 trial took place across 11 medical centers in the United States. Participants, aged 21-65, with severe depression lasting at least 60 days, and with a moderate or higher symptom severity level, were randomly assigned in a 1:1 ratio to receive a single dose of psilocybin or a niacin placebo, both with psychological support. Patients with a history of psychosis, bipolar disorder, substance use disorder, or current suicidal ideation were excluded.
A total of 104 participants were included in the intention-to-treat analysis, with 50 in the psilocybin group and 54 in the placebo group. At week 6, 1 participant in the psilocybin group and 9 in the placebo group dropped out or were lost to follow-up. Three participants in each group initiated antidepressant medication before the trial's end (day 43), with 2 in the psilocybin group and 1 in the placebo group also starting psychotherapy. No participants withdrew due to adverse events.
The psilocybin group demonstrated a significantly greater reduction in MADRS scores at day 43 compared to baseline (mean difference -12.3, p<0.001), as well as at day 8 (mean difference -12.0, p<0.001).
Image
Reduction in MADRS scores for the Psilocybin (yellow) and Placebo (blue) groups.
The psilocybin group had more participants with sustained treatment response (20/48 [42%] vs. 5/44 [11%], adjusted absolute difference 30.3, p=0.002). There was also a higher rate of sustained remission in the psilocybin group, but this difference did not reach statistical significance (12/48 [25%] vs. 4/44 [9.1%], adjusted absolute difference 15.9, p=0.05). The psilocybin group had a greater reduction in functional disability scores as assessed by the Sheehan Disability Scale (-2.31, p<0.001).
Psilocybin treatment was associated with improvements in various exploratory endpoints, including overall disease severity reduction, self-reported depressive and anxiety symptoms, and quality of life, but it had no effect on emotional blunting.
Both the psilocybin and placebo groups reported adverse events, with 44 (88%) and 33 (61%) participants, respectively, experiencing at least one adverse event. Within 9 days after dosing, 41 (82%) in the psilocybin group and 24 (44%) in the placebo group reported at least one drug-related adverse event, decreasing to 2 (4%) and 1 (2%) between days 10-43. There were no suicide or self-harm behaviors during the trial, and no clinically significant changes in vital signs or laboratory results were observed.
In summary, the results of this trial suggest that a 25mg single dose of psilocybin is more effective than placebo in improving depression symptoms with a high rate of sustained response and remission. Psilocybin was generally well-tolerated, with most adverse events being mild to moderate and typically limited to the acute dosing period.
Image
In a concurrent commentary, the authors point out that while psychedelic therapy may not be effective for every individual with depression, it represents a new approach to mental health treatment and a potential paradigm shift in disease management. Research into the mechanisms of action of psychedelic substances may also provide new insights into neuronal plasticity and brain function.](https://medicaltrend.org/wp-content/uploads/2023/09/230901mm33.webp)
In a concurrent commentary, the authors point out that while psychedelic therapy may not be effective for every individual with depression, it represents a new approach to mental health treatment and a potential paradigm shift in disease management.
Research into the mechanisms of action of psychedelic substances may also provide new insights into neuronal plasticity and brain function.
Clinical Trials Confirm the Efficacy of Psilocybin for Severe Depression
(source:internet, reference only)
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