Determining the effect of adding oral vitamin C to the standard treatment of major depressive disorder in patients referred to the clinics of Shahid Sadoughi University of Medical Sciences, Yazd
Design
This clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 is performed on 90 patients with major depressive disorder. For randomization, a simple random method is used using the card selection method from inside the box.
Settings and conduct
This clinical trial study was performed in 1400 and 1401 in Shahid Sadoughi Hospital in Yazd. The study was conducted as a double-blind study and patients and the person evaluating the outcome of treatment were unaware of the type of drug received.
Participants/Inclusion and exclusion criteria
In this study, patients with major depressive disorder who are at least 18 years old, have a minimum literacy and have the ability and conditions to answer questions are included in the study. Addicted patients, patients with underlying diseases, patients who have changed their diet in the past month are not included in the study.
Intervention groups
Patients in the intervention group will be given 500 mg of vitamin C tablets twice a day and in the control group, placebo tablets will be prescribed in the same way for 2 months.
Main outcome variables
mprove the symptoms of major depressive disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N56
Registration date:2021-07-12, 1400/04/21
Registration timing:prospective
Last update:2021-07-12, 1400/04/21
Update count:0
Registration date
2021-07-12, 1400/04/21
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding oral vitamin C to standard treatment of major depressive disorder
Public title
The effect of adding vitamin C tablets to the treatment regimen of patients with major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having major depressive disorder
Patient consent to participate in the study
Minimum literacy
Has a high level of consciousness
Has suitable conditions for completing the questionnaire
Exclusion criteria:
Drug addiction
Underlying diseases such as diabetes, cardiovascular, lung, cancer
Major changes in diet in recent months
Verbal and auditory problems in which they are unable to communicate
Antioxidant use one month before enrollment,
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are distributed in two groups by simple random allocation method. To do this, the letter A is written on 45 cards and the letter B is written on 45 cards, and all the cards are placed in a box and mixed well. Patients take a card out of the box when they visit and the patient is assigned to the intervention or control group according to what is written on the card.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is done in two blinds. Patients and the person evaluating the outcome of treatment are unaware of the type of medication used by patients. Drugs are prepared in similar packages and coded by the project manager and are provided to patients for consumption.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadughi University of Medical Sciences
Street address
Shohadaye Gomnam street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2021-02-09, 1399/11/21
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.291
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Intensity of Major Depressive Disorder
Timepoint
Before the intervention, one month and two months after the start of the intervention
Method of measurement
Using the Hamilton Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Daily administration of 500 mg of vitamin C tablets twice a day, in addition to routine treatment of major depressive disorder for two months.
Category
Treatment - Drugs
2
Description
Control group: Prescribe a placebo similar to 500 mg vitamin C tablets twice a day for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric Clinic of Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Mahsa Mahdavi
Street address
Shohadaye Gomnam street
City
Yazd
Province
Yazd
Postal code
8434193474
Phone
+98 31 3669 2174
Email
mahsa.mahdavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shohadaye Gomnam street
City
Yazd
Province
Yazd
Postal code
8434193474
Phone
+98 31 3669 2174
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohamad Nadi Sakhvidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shohadaye gomnam street
City
Yazd
Province
Yazd
Postal code
8434193474
Phone
+98 31 3669 2174
Email
nadi.sakhvidi@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Reza Bidaki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shohadaye Gomnam street
City
Yazd
Province
Yazd
Postal code
8434193474
Phone
+98 31 3669 2174
Email
r_bidaki@med.ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
hkaveh57@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The project belongs to a government organization and it is not possible to share it.