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IRCT20170311033004N4 IRCT 2022-06-28 Iranian academic center for education culture and research 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 2022-07-23 anticipated 68 Complete https://irct.ir/trial/64398 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed through block randomization (block of four). In Excel, we would arrange the Treatment and Control values systematically and then add a column with a block number. The third column would be our random numbers. Here is what it would look like. Then, we sort the numbers, by block and by random number within block, Blinding description: Blinding and randomization will be carried out by an independent person unrelated to the study, while the investigator will administrate capsules and will assess the patients. Capsules will be packed and numbered serially using numbers generated by random number tables. They are the same in appearance, size, and color. 2 Posttraumatic stress disorder (PTSD). 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 the capsules, prepared in an opaque plastic container. Patients received powder capsules (equivalent 20 mg alkaloids), standardized to reference. Intervention 2: Control group: Control group: Placebo capsules, with the exact size, color, and appearance, were filled with fried bread. Yes - There is a plan to make this available What will be shared: demographic data and questionnaire final scores will be shared. When: after publication To whom: Researchers from all the medical universities Conditions: The data can be used results in review articles. Where to obtain: The data is available by calling Dr Ali Razmi; assistant professor at ACECR. email: arazmi@alumnus.tums.ac.ir Tel: 00989123945632 How to obtain: The request should be sent to the email. Comments:
public Ali Razmi
Institute of medicinal plants, Alborz science and technology park, Kamalshahr
Karaj Iran (Islamic Republic of) 3365166571 +98 26 3476 4015 arazmi@alumnus.tums.ac.ir Iranian academic center for education culture and research scientific Ali Razmi
Kamalshahr, Jahad daneshgahi research complex
Kamalshahr Iran (Islamic Republic of) 3365166571 +98 26 3476 4010 arazmi@alumnus.tums.ac.ir Iranian academic center for education culture and research Iran (Islamic Republic of) 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 45 years 75 years Male 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 F43.1 Post-traumatic stress disorder (PTSD) Treatment - Drugs Treatment - Drugs 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 the capsules, prepared in an opaque plastic container. Patients received powder capsules (equivalent 20 mg alkaloids), standardized to reference. Control group: Control group: Placebo capsules, with the exact size, color, and appearance, were filled with fried bread. 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. Iranian academic center for education culture and research Approved 2022-06-19 دانشگاه علوم پزشکی ارتش جمهوری اسلامی ایران Chamran highway Tehran Tehran Iran (Islamic Republic of)