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Evaluation of adjunctive therapy of seeds alkaloids of Peganum harmala in the treatment of mild to moderate depression

Protocol summary

Study aim
Evaluation of the Peganum harmala seed's alkaloids in mild-moderate depressive disorder
Design
A randomized (block randomization), blinded, placebo-controlled clinical trial with treatment (the alkaloids) group and 68 sample size. 1) The treatment group will receive hamala alkaloids and SSRIs, while 2) the placebo group will take fried bread and SSRIs for 6 weeks.
Settings and conduct
The capsules will be prepared in an opaque plastic container. Each container will consist of 42 hard gelatin capsules. The study was conducted in the outpatient Kasra Clinic, Karaj. Demographic characteristics of patients are registered at the start of the study. Evaluations include HAMD, and BDI scores are recorded on days 0, 28, and 42. Additionally, laboratory tests CBC, ALS, AST, and ALP will be performed at D0 and D7.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the ability to read, understand, and sign the informed consent form and the study procedures; both genders; aged 18–65 years; without any previous diagnosis of other mental disorders such as bipolar disorder, psychosis, primary anxiety disorder, and substance abuse or dependence disorder; reporting the Hamilton Depression Rating Score (HAMD) score above 14; agreed to use suitable family planning methods during the study and three months afterward. Exclusion criteria: smoking; pregnancy; under treatment but SSRIs.
Intervention groups
Control group: Placebo which will receive fried bread in capsule form in addition to SSRIs. Intervention group: Harmal alkaloids which will receive alkaloids' fraction of Peganum Harmala seeds in addition to SSRIs.
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: IRCT20170311033004N3
Registration date: 2022-02-01, 1400/11/12
Registration timing: prospective

Last update: 2022-02-01, 1400/11/12
Update count: 0
Registration date
2022-02-01, 1400/11/12
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
2022-04-03, 1401/01/14
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of adjunctive therapy of seeds alkaloids of Peganum harmala in the treatment of mild to moderate depression
Public title
Effects of alkaloids of harmala seeds on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ability to read, understating and sign the informed consent form and the study procedures male or female aged 18–65 years without any previous diagnosis of other mental disorders such as bipolar disorder, psychosis, primary anxiety disorder, and substance abuse or dependence disorder reporting the Hamilton Depression Rating Score (HAMD) score above 14 agreed to use suitable family planning methods during the study and three months afterward non-smoking not being pregnant under only SSRIs antidepressant regimen
Exclusion criteria:
they have a current diagnosis of other mental disorders including bipolar disorder, psychosis, primary anxiety disorder, and substance abuse or dependence disorder pregnancy and breastfeeding taking antidepressant except for SSRIs, mood stabilizer, or antipsychotic drug chemotherapy or other medications known to produce mood changes sensitivity to harmala alkaloids emerging serious adverse effects with the alkaloids
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
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
Avicenna Research Institute
Street address
Darakeh St., Shahid Beheshti University
City
Tehran
Province
Tehran
Postal code
1983969412
Approval date
2020-10-06, 1399/07/15
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1399.020

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F33.1
ICD-10 code description
Major depressive disorder, recurrent, moderate

Primary outcomes

1

Description
Anhedonia, depressed mood, change in appetite, sleep, and suicidal ideations
Timepoint
Week 0, 4 and 6
Method of measurement
Hamilton Depression Rating Scale score

2

Description
Depression
Timepoint
Week 0, 4 and 6
Method of measurement
Beck Depression Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: harmala alkaloids: Extraction is performed through routine methods for alkaloids extraction. Then a semi-automatic capsule filler was used to fill the harmaline capsules, prepared in an opaque plastic container. Each container consists of 42 hard gelatin capsules for six weeks of intake. Patients received either harmaline powder capsules (10 mg) per day, standardized to reference harmaline. Each capsule contained an equivalent 10 mg harmaline powder. All capsules were manufactured and packed in the Institute of Medicinal Plants (IMP), Alborz, Iran.
Category
Treatment - Drugs

2

Description
Control group: placebo: Placebo capsules, with the exact size, color, and appearance, were filled with fried bread (Roshd Co. Yazd, Iran). A semi-automatic capsule filler was used to fill the placebo capsules. Each container consists of 42 hard gelatin capsules for six weeks of intake. All capsules were manufactured and packed in the Institute of Medicinal Plants (IMP), Alborz, Iran.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kasra polyclinic
Full name of responsible person
Vahdad Varzaghani
Street address
Jahanshahr, Karaj, Kasra Polyclinic
City
Karaj
Province
Alborz
Postal code
3144915598
Phone
+98 26 3444 0600
Email
vahdadvar@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Gholamreza Esmaeeli Djavid
Street address
No 1270, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1314744513
Phone
+98 21 6649 1533
Fax
+98 21 6649 1533
Email
international@acecr.ac.ir
Web page address
http://acecr.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 professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Kamalshahr, Jahad daneshgahi research complex
City
Kamalshahr
Province
Alborz
Postal code
1689734337
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
arazmi@alumnus.tums.ac.ir
Web page address

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
1689734337
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
1689734337
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
Yes - There is 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, the total score of questionnaires, and laboratory test's results
When the data will become available and for how long
Immediately after publishing the data
To whom data/document is available
Researchers at medical universities
Under which criteria data/document could be used
Scores of the questionnaires and laboratory data are available for reviews and meta-analyses.
From where data/document is obtainable
Dr Ali Razmi assistant professor of the institute of medicinal plants is responsible for sharing data email: a.razmi@yahoo.com Tel: 00989123945632
What processes are involved for a request to access data/document
Applicants could send their requests through email. The data will be available after identification.
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