The effect of magnesium supplements on serum brain-derived neurotrophic factor and depression status in patients with depression
Design
Controlled clinical trial, with parallel groups, blind two-sided, randomized
Settings and conduct
We selected 46 depressed patients referring to Zahedan Baharan Psychiatric Clinic and then divided them into two groups of intervention (23 patients) and control (23 people) using randomized random sampling.The intervention group received 500 mg magnesium oxide tablets daily (2 tablets 250 mg)and the control group also receives 2 placebo tablets (containing starch) for 8 weeks.The patients and the curative staff who provide the pills to patients do not have any information about the contents of the intervention
Participants/Inclusion and exclusion criteria
Entry requirements; all people with depression are diagnosed,Age range 20 to 60 years old. Exclusion conditions: schizophrenia; bipolar disorder; kidney disease; myasthenia gravis; gastrointestinal disease; surgery scheduled in the next three months; use of a drug that interferes with magnesium; acute heart failure.
Intervention groups
The intervention group received 500 mg magnesium oxide tablets daily (2 tablets 250 mg)and the control group also receives 2 placebo tablets (containing starch) for 8 weeks.
Main outcome variables
Depression; BDN; magnesium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190317043084N1
Registration date:2019-03-26, 1398/01/06
Registration timing:prospective
Last update:2019-03-26, 1398/01/06
Update count:0
Registration date
2019-03-26, 1398/01/06
Registrant information
Name
Maryam Afsharfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3392 7160
Email address
maryam.afshaar.1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplementation of magnesium on serum Level of BDNF and depression status in patients with depression
Public title
The effect of magnesium supplements on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged between 20-60 years old and whose depression is diagnosed by the relevant psychiatrist
Exclusion criteria:
Schizophrenia Bipolar disorder kidney disease Myasthenia Graves Gastrointestinal disease
Surgery scheduled in the next three months
Use of a drug that interferes with magnesium
Acute heart failure
Age
From 20 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly with the help of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the curative staff who provide the pills to patients do not have any information about the contents of the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hesabi Square, Zahedan Medical Science Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.ZAUMS.REC.1397.513
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32, F33
ICD-10 code description
This block contains disorders in which the fundamental disturbance is a change in affect or mood to depression (with or without associated anxiety) or to elation. The mood change is usually accompanied by a change in the overall level of activity; most of
Primary outcomes
1
Description
Depression Score in Beck Questionnaire
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Beck Depression Inventory
Secondary outcomes
1
Description
BDNF
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Measuring with laboratory kit on blood sample
2
Description
Serum magnesium
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Serum magnesium test
Intervention groups
1
Description
Intervention group: consists of 23 depressed people who receive two tablets of magnesium oxid tablets daily after breakfast and one after dinner for 8 weeks, and after 8 weeks again, Beck Depression Test for Depression and Magnesium Serum Assay and BDNF for Measurement The state of magnesium and BDNF is performed.
Category
Treatment - Drugs
2
Description
Control group: consists of 23 depressed people receiving twice daily placebo tablets that have the same shape and color as the original pill, receive one after breakfast and one after dinner for 8 weeks, and again after 8 weeks, Beck Depression Test Serum magnesium and BDNF depression tests are used to measure the magnesium and BDNF status.