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Evaluation of efficacy and safety of Psilocybe mushroom on depression and post-traumatic stress disorder symptoms in veterans

Evaluation of efficacy and safety of Psilocybe cubensis on depression and PTSD symptoms of veterans; a randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170311033004N4
Enrollment
68
Registered
2022-06-28
Start date
2022-07-23
Completion date
Unknown
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic stress disorder (PTSD). Post-traumatic stress disorder (PTSD)

Interventions

Intervention 1: Intervention group: Psilocybe cubensis alkaloids: ?The alkaloids purified through routine methods for alkaloids purifications. Then a semi-automatic capsule filler was used to fill the

Sponsors

Iranian academic center for education culture and research
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: patients with PTSD diagnosis moderate to severe depression male aged 45-75 years without any previous diagnosis of other mental disorders such as without any previous diagnosis of diabetes or CV disorders without diagnosis of the other mental disorders taking antidepressants SSRIs or SNRIs not hospitalized

Exclusion criteria

Exclusion criteria: they have a diagnosis of psychosis suicide attempting taking antidepressants except for SSRIs and SNRIs or electroconvulsive therapy follow up interrupting sensitivity to the mushroom emerging adverse effects including fever, GI and heart diseases hospitalization

Design outcomes

Primary

MeasureTime frame
Anhedonia, depressed mood, change in appetite, sleep, BAI score, and suicidal ideations. Timepoint: Days 0, 28 and 42. Method of measurement: BAI, HDRS and PCL-V questionnaires.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Razmi

Iranian academic center for education culture and research

arazmi@alumnus.tums.ac.ir+98 26 3476 4015

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026