Protocol summary

Study aim
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 24 3347 3657
Email address
islambulchilarm@zums.ac.ir
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
Method of measurement
Beck and Hamilton scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: receiving acid folic 1mg/day (Rouz Darou) and citalopram 20 mg/day
Category
Treatment - Drugs

2

Description
Control group: citalopram 20 mg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Haft tir clinic of Zanjan
Full name of responsible person
Masume Morovati
Street address
Gavazang blvd,school of pharmacy, Zanjan university of medical sciences
City
Zanjan
Province
Zanjan
Postal code
45139-56184
Phone
+98 24 3347 3635
Fax
+98 24 3347 3639
Email
masumeh.m71@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Azadi Blv., Zanjan university of medical sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 4770
Fax
+98 24 3342 4770
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Islambulchilar Mina
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Gavazang blvd,school of pharmacy, zanjan university of medical sciences
City
Zanjan
Province
Zanjan
Postal code
45139-56184
Phone
+98 24 3347 3635
Fax
+98 24 3347 3639
Email
islambulchilar.mina@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Islambulchilar Mina
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Nxt. Mousavi Hos, gavazang Rd. ZUMS
City
Zanjan
Province
Zanjan
Postal code
45195-1338
Phone
+98 24 3347 3635
Fax
+98 24 3347 3639
Email
islambulchilar.mina@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Masume Morovati
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Nxt. mousavi Hospital, Gavazang rd. Zanjun university of medical science
City
Zanjan
Province
Zanjan
Postal code
45195-1338
Phone
+98 24 3347 3635
Fax
+98 24 3347 3639
Email
masumeh.m71@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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