This randomized, double-blinded clinical trial is conducted on patients with major depressive disorder, aged 20-50 years. Patients with psychotic symptoms are excluded from the study. Patients in both groups receive the standard treatment for major depressive disorder consisting of 20 mg citalopram, daily. The cases receive 2.5 mg of folic acid per day and the controls are treated with placebo. The outcomes are evaluated using the Beck Depression Inventory and reduction of the depression score is interpreted as the response to treatment. Outcomes are measured at 4, 6 and 8 weeks after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082518922N1
Registration date:2014-12-06, 1393/09/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-06, 1393/09/15
Registrant information
Name
Narges Gholampoor
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
gholampour@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2013-11-06, 1392/08/15
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Folic acid supplementation on response to the standard treatment in patients with major depressive disorder.
Public title
Effect of Folic acid supplementation on the therapeutic regimen for major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: To have a definite diagnosis of major depressive disorder according to the DSM-IV-TR criteria; Being between 20 and 50 years old; To get the minimum score of 12 from the BDI 2 scoring system; Having stopped taking any other antidepressant medications since 4 weeks before starting folic acid; Patients who sign the written informed consent after being provided with the detailed information about the study; Not having anemia based on a Complete Blood Count (CBC) test; The absence of pregnancy; No alcohol or substance use in 6 months prior to the study; The absence of manic episodes; The absence of psychotic symptoms; The absence of mental retardation; Depression not due to a general medical condition or substance; The absence of any severe or chronic physical illnesses.
Exclusion criteria: Having any acute and severe medical conditions; The incidence of any severe psychiatric disorders (suicidal thoughts, psychotic symptoms, manic phase symptoms, etc.); Failure to follow-up for at least 4 weeks; The concomitant use of other psychotropic drugs; The incidence of severe complications during treatment.
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Vice chancellor for research, Kashan Medical Sciences complex, Ghotbe Ravandi Blvd.
City
Kashan
Postal code
Approval date
2013-10-26, 1392/08/04
Ethics committee reference number
29/5/1/458/پ
Health conditions studied
1
Description of health condition studied
Major depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
depression severity
Timepoint
4, 6 and 8 weeks after starting the treatment
Method of measurement
The Beck Depression Inventory 2nd Edition
Secondary outcomes
empty
Intervention groups
1
Description
Folic acid tablet, one half of 5 mg tablets, once per day for 8 weeks
Category
Treatment - Drugs
2
Description
Tablets without the active ingredient with the same size and shape of Folic acid tablet, a half tablet daily, for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Kargarnejad Hospital
Full name of responsible person
Dr. Narges Gholampur
Street address
Kargarnejad Hospital, Ghotbe Ravandi Blvd.
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Vice Chancellor for research, Pezeshk Blvd., Ghotbe Ravandi Blvd.
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Kashan University of Medical Sciences