Our study objective is to evaluate the effect of citicoline as a supplementary drug in treatment of patients suffering from depression in the range of medium to sever, who receive citalopram as the main drug, in a double blind controlled clinical trial.
Fifty patients diagnosed as depressed, with a score of above 18 on Hamilton Rating Scale for Depression (HRSD), are going to be selected and randomly assigned to two groups. First group of patients receive citalopram & citicoline every 12 hours for six weeks. This is called treatment group. Second group of patients receive citalopram and placebo-100 mg every 12 hours for six weeks. This is called controlled group.
Assessments are taken by psychiatrists on 2nd, 4th and 6th weeks after onset of receiving medication. Intensity changes of depression will be assessed with the help of HRSD score and will be carried out by psychiatrists
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502191556N74
Registration date:2015-08-29, 1394/06/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-08-29, 1394/06/07
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Citichholine as adjuvant therapy in major depression: a randomized and double blind study
Public title
The effect of Citicoline in major depression
Purpose
Treatment
Inclusion/Exclusion criteria
aInclusion criteria: age between 18 – 50 years old; diagnoses are done on the basis of Diagnostic &
Statistical Mental Disorders (DSMD); HRSD score above14; signing informed consent.
Exclusion criteria: demise of a close relative; having other psychocognitive affliction; taking antidepressive & psychoactive drugs within the last two months; heart complication; thyroid complication; history of ECT (Electroconvulsive Therapy); alcohol & drug addiction; reaching menopause age; pregnancy and lactation.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2014-07-26, 1393/05/04
Ethics committee reference number
24687
Health conditions studied
1
Description of health condition studied
Major depression
ICD-10 code
F32
ICD-10 code description
Major Depressive episode
Primary outcomes
1
Description
Severity of depression
Timepoint
Assessment in first and on 2th, 4th and 6th weeks after onset of receiving medication
Method of measurement
Measurment by HAMD
Secondary outcomes
empty
Intervention groups
1
Description
Citalopram 40 mg /day plus capsule citicolin 100 mg BID as the main drug for six weeks as the intervention group
Category
Treatment - Drugs
2
Description
Citalopram 40 mg/day plus Placebo for six weeks as the control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo hospital
Full name of responsible person
Dr. Samrand Salimi
Street address
Baharloo hospital, Rahahan squre
City
Tehran
2
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Dr. Aliakbar Nejatisafa
Street address
Rouzbeh hospital, South Kargar street
City
Tehran
3
Recruitment center
Name of recruitment center
Immam Khomeini hospital
Full name of responsible person
Dr. Mohammad Arbabi
Street address
Immam Khomeini hospital, Dr. Gharib street, Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Medical Sciences University
Full name of responsible person
Dr. Massod Yunesian
Street address
Tehran University of Medical Sciences, Ghods Avn., Keshavarz Blvd.,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Medical Sciences University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of Medical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh hospital, South Kargar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
sakhond@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of Medical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh hospital, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
sakhond@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of Medical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh hospital, South Kargar Street,
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
sakhond@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)