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

Protocol summary

Study aim
pharmacologic evaluation of the alkaloids extracted from psilocybe cubensis on symptoms of Post-traumatic stress disorder (PTSD)
Design
Purification of the alkaloids will be performed through a common method designed for alkaloids specifically. A chromatographic method (HPLC) will be used to detect the amount of psilocybin. Then, we formulate solid capsule dosage forms with 20 milligrams of psilocybin in a capsule. A randomized, double-blind, placebo-controlled clinical trial with treatment (the alkaloids) group and 68 sample size. 1) The treatment group will receive alkaloids and the common antidepressants (SSRIs or SNRIs), while 2) the placebo group will take fried bread and SSRIs for 6 weeks.
Settings and conduct
The study was conducted in the outpatient at 505 hospital. Demographic characteristics of patients are registered at the start of the study. Evaluations include HAMD, PCL-V, and BAI scores are recorded on days 0, 28, and 42
Participants/Inclusion and exclusion criteria
veterans with a diagnosis of Post-traumatic stress disorder (PTSD)
Intervention groups
1) Control group: will receive a single dose of placebo capsules, with the exact size, color, and appearance were filled with fried bread at the first of the study 2) treatment group: will receive a single dose of 20 milligrams of alkaloids extracted from the psilocybe mushroom at the first of the study
Main outcome variables
depressed mood; Feelings of guilt; Suicide; Insomnia (early, middle, and late insomnia ); Work and interests; Psychomotor retardation; Psychomotor agitation; Anxiety, psychic; Anxiety, somatic

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170311033004N4
Registration date: 2022-06-28, 1401/04/07
Registration timing: prospective

Last update: 2022-06-28, 1401/04/07
Update count: 0
Registration date
2022-06-28, 1401/04/07
Registrant information
Name
Ali Razmi
Name of organization / entity
Academic Center for Education, Culture and Research
Country
Iran (Islamic Republic of)
Phone
+98 26 3476 4015
Email address
arazmi@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of Psilocybe cubensis on depression and PTSD symptoms of veterans; a randomized, double-blind, placebo-controlled trial
Public title
Evaluation of efficacy and safety of Psilocybe mushroom on depression and post-traumatic stress disorder symptoms in veterans
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 45 years old to 75 years old
Gender
Male
Phase
2
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
دانشگاه علوم پزشکی ارتش جمهوری اسلامی ایران
Street address
Chamran highway
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2022-06-19, 1401/03/29
Ethics committee reference number
IR.AJAUMS.REC.1401.024

Health conditions studied

1

Description of health condition studied
Posttraumatic stress disorder (PTSD)
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)

Primary outcomes

1

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
Control group: Control group: Placebo capsules, with the exact size, color, and appearance, were filled with fried bread.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
AJA 505 hospital
Full name of responsible person
Mohammad Reza Ghasemzadeh
Street address
Artesh highway, Oshan Blvd
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2248 1806
Email
m.rezaghasemzadeh@yahoo.com
Web page address
https://bima505.ajaums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Ali Razmi
Street address
Enghelab street, facing University of Tehran, central office
City
Tehran
Province
Tehran
Postal code
436414155
Phone
+98 21 6648 8515
Fax
+98 21 6648 8518
Email
secretariat@acecr.ac.ir
Web page address
http://acecr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Ali Razmi
Position
Assistant preofessor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Institute of medicinal plants, Alborz science and technology park, Kamalshahr
City
Karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4015
Fax
+98 26 3476 4021
Email
arazmi@alumnus.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Ali Razmi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Kamalshahr, Jahad daneshgahi research complex
City
Kamalshahr
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
arazmi@alumnus.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Ali Razmi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Kamalshahr, Jahad daneshgahi research complex
City
Kamalshahr
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
arazmi@alumnus.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
demographic data and questionnaire final scores will be shared.
When the data will become available and for how long
after publication
To whom data/document is available
Researchers from all the medical universities
Under which criteria data/document could be used
The data can be used results in review articles.
From where data/document is obtainable
The data is available by calling Dr Ali Razmi; assistant professor at ACECR. email: arazmi@alumnus.tums.ac.ir Tel: 00989123945632
What processes are involved for a request to access data/document
The request should be sent to the email.
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