Comparison of the effect of simultaneous administration of folic acid supplements in patients with major depressive disorder treated with selective serotonin reuptake inhibitors in patients who are only being treated with selective serotonin reuptake inhibitors.
Design
Clinical trial with control and intervention group, randomized
Settings and conduct
This study is carried out at the Zanjan Haft-Tir Clinique.
Participants/Inclusion and exclusion criteria
The patient is depressed, the Beck test result is above 15, the absence of other psychiatric disorders and psychosis, bipolar disorder, drug abuse, depression due to physical illness, pregnancy
Intervention groups
Control group: Depressed patients with a Beck score of over 15 who were only treated with citalopram.
Intervention group: Depressed patients with a Beck score of over 15 who were treated with citalopram with folic acid.
Main outcome variables
The level of blood folate, the severity of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180115038373N1
Registration date:2018-10-06, 1397/07/14
Registration timing:retrospective
Last update:2018-10-06, 1397/07/14
Update count:0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
Mina Islambulchilar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 4798
Email address
islambulchilar.mina@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
2018-01-05, 1396/10/15
Actual recruitment end date
2018-09-06, 1397/06/15
Trial completion date
2018-09-06, 1397/06/15
Scientific title
Effects of folic acid supplementation in patients with major depressive disorder receiving Citalopram.
Public title
effect of folic acid in depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
depressed people, the number of beck scale should be more than 15
Exclusion criteria:
having other psychotic disorders, like psychos, bipolar disorder, drug abusers,pregnancy, and depression because of an illness
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
30
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were available from clients referring to the psychiatric clinic, then placed in a control or intervention group from a bag containing 30 arrays containing 15 orbets with a label A and 15 orbets labeled B (control group: A The intervention group: B) took an orb
Blinding (investigator's opinion)
Single blinded
Blinding description
ُStudy cases have been evaluated by our psychologist colleagues, by Hamilton test ( tested depression severity),
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan university of medical sciences
Street address
Gavazang blvd,school of pharmacy, Zanjan university of medical sciences
City
Zanjan
Province
Zanjan
Postal code
45139-56184
Approval date
2018-01-02, 1396/10/12
Ethics committee reference number
IR.ZUMS.REC.1396.246
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32.2
ICD-10 code description
Major depressive disorder, single episode, severe without psychotic features
Primary outcomes
1
Description
Depression severity with the results of Beck scale
Timepoint
Measureing the severity of depression at the beginning of the study, day 45, day90