Determining the effect of magnesium supplementation on improving depressive symptoms in patients with major depressive disorder treated with antidepressants (SSRIs)
Design
A clinical trial with a control group, parallel groups, two-way blind, randomized, phase 3 was performed on 48 patients and random table method was used for randomization.
Settings and conduct
The study was conducted in Golestan Hospital of Ahvaz after selecting patients with major depression. They were randomly divided into two groups. Intervention group was treated with selective serotonin inhibitors and magnesium supplement at a dose of 250 mg per day for 6 weeks. The control group was treated with selective serotonin inhibitors and placebo.Then, information was collected through Beck questionnaire and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria were patients with major depression based on DSM-S and according to the diagnosis of a psychiatrist over 18 years of age and having minimum education to read the questionnaire.
Exclusion criteria include neurological disorders, alcohol and drug use over the past 6 months, active suicidal ideation, pregnancy and lactation, mental retardation, liver and kidney failure, receiving monooxidase inhibitors during the last 8 weeks, and a history of seizures. Also, the use of drugs that interfere with magnesium and the presence of uncontrolled diseases such as diabetes and high blood pressure and allergies to antidepressants or magnesium supplements are other parameters that cause patients to leave the study.
Intervention groups
The intervention group was treated with selective serotonin inhibitors with magnesium supplement at a dose of 250 mg per day for 6 weeks and the control group was treated with selective serotonin inhibitors with placebo for 6 weeks.
Main outcome variables
Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200823048493N1
Registration date:2020-10-25, 1399/08/04
Registration timing:retrospective
Last update:2020-10-25, 1399/08/04
Update count:0
Registration date
2020-10-25, 1399/08/04
Registrant information
Name
Sousan Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3441 6074
Email address
dr.sadeghi_45@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
2019-06-10, 1398/03/20
Actual recruitment end date
2020-09-10, 1399/06/20
Trial completion date
2020-10-21, 1399/07/30
Scientific title
The effect of adding magnesium supplement on depressive symptoms in patients with major depressive disorder treated with antidepressants (SSRI
Public title
The effect of magnesium supplementation in improving depressive symptoms in patients with major depressive disorder treated with antidepressants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with major depression based on DSM-S and according to the diagnosis of a psychiatrist
Age over 18 years
Having minimum education to read the questionnaire
Exclusion criteria:
Neurological disorders
Taking alcohol and drug use during the last 6 months
Active suicidal thoughts
Pregnancy and lactation
Mental retardation
Liver and kidney failure
Receiving monooxidase inhibitors during the last 8 weeks
History of seizures
Taking magnesium-interfering drugs
Presence of uncontrolled diseases such as diabetes and high blood pressure
Allergy to antidepressants or magnesium supplements
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
We divided each referral into two groups using a randomized table. This table was a collection of numbers. We Considered number from 1 to 24 for intervention and numbers 25 to 48 for control. Then we toughed one of the numbers and moved in one of the preset directions and assigned the numbers to one of the groups. Thus, patients were completely randomly divided.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients did not know about prescription drugs (placebo and drug). Also, the researcher (the person who provided these drugs to the patients) did not know about the assignment of patients to placebo and drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Ahwaz University of Medical Sciences, Golestan Blvd, Ahwaz
City
َAhwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR. AJUMS. REC.1398. 917
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32.3
ICD-10 code description
Major depressive disorder, single episode, severe with psychotic features
Primary outcomes
1
Description
Depression
Timepoint
In weeks 0, 2, 4 6
Method of measurement
Via Beck Depression Inventory
Secondary outcomes
1
Description
Side effects such as diarrhea
Timepoint
6 weeks after intervention
Method of measurement
Through questions from the patient.
Intervention groups
1
Description
The intervention group was treated with selective serotonin inhibitors (sertraline, citalopram, fluoxetine and fluoxacin) along with magnesium supplement at a dose of 250 mg per day for 6 weeks.
Category
Treatment - Drugs
2
Description
The intervention group was treated with selective serotonin inhibitors (sertraline, citalopram,fluoxetine and fluoxacin) along with placebo per day for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Susan Sadeghi
Street address
Golestan hospital, Golestan Street, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3001
Email
dr.sadeghi_45@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Vice Chancellor for Research,Ahvaz University of Medical Sciences, Golestan Blvd, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
15794 -61357
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Susan Sadeghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ahwas University of Medical Sciences, Golestan Blvd, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
15794 -61357
Phone
+98 61 3374 3001
Email
dr.sadeghi_45@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Susan Sadeghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ahwaz University of Medical Sciences, Golestan Blvd, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
15794 - -61357
Phone
+98 61 3374 3001
Email
dr.sadegh_45@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Susan Sadeghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz University of Medical Sciences, Golestan Blvd, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3001
Email
Dr.sadeghi_45@yahoo.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
Participants' consent for publication must be available