Comparison of efficacy of Citalopram plus L-carnosin and Citalopram plus placebo in Major Depressive Disorder
Design
Two arm parallel group randomized trial with blinded outcome and side effects assessment
Settings and conduct
Subjects will be included in psychiatric clinics of Iran Psychiatry Hospital, Tehran Psychiatry Institute and Farshchian Hospital(Hamadan).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who meet DSM-IV-TR criterion for MDD .They should be 18-60 years old and they achieve more than 18 for Hamilton Depression Scale (HamD) and sign consent form.
Exclusion criteria:
Substance abuse except Nicotine for 1 year before enterance, treated by any anti-depressant medication for 1 month ago, treated by ECT for 2 months ago, presence of psychotic feature, previous diagnosed as Bipolar patient, suicidal thoughts.
In addition, they will evaluate for thyroid, cardiac, liver, kidney diseases, or any medical cause for depression, pregnancy, lactation before entrance and any mentioned conditions will cause exclusion from study
Intervention groups
Patients will be randomized divided into 2 groups: First group will be treated with Citalopram tablet (max. 20mg/day) plus L-carnosine tablet (400mg twice per day) for 6 weeks and another group will be treated with Citalopram tablet (max. 20mg/day) plus placebo for 6 weeks.
Main outcome variables
Severity of Major Depressive Disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170123032145N2
Registration date:2018-04-13, 1397/01/24
Registration timing:registered_while_recruiting
Last update:2018-04-13, 1397/01/24
Update count:0
Registration date
2018-04-13, 1397/01/24
Registrant information
Name
Mohammadreza Shalbafan
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1665
Email address
shalbafan.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
L-carnosine as an adjuvant in treatment of major depressive disorder : a randomized double-blind study
Public title
L-carnosine in treatment of major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who meet DSM-IV-TR criterion for MDD
They should be 18-60 years old and
They achieve more than 18 for Hamilton Depression Scale (HamD)
Sign consent form
Exclusion criteria:
Substance abuse except Nicotine for 1 year before enterance
Treated by any anti-depressant medication for 1 month ago
Treated by ECT for 2 months ago
Presence of psychotic feature
Previous diagnosed as Bipolar patient
Suicidal thoughts
They will evaluate for thyroid, cardiac, liver, kidney diseases, or any medical cause for depression, pregnancy, lactation before entrance and any mentioned conditions will cause exclusion from study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Investigators who include subjects or evaluate response or side effects are not aware that which group 1/2 is case/control.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Exp. way, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-01-05, 1396/10/15
Ethics committee reference number
IR.IUMS.FMD.REC 1396.٩٤١١٢٨٦٠٠١
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Hamilton Depression Scale score
Timepoint
0, 2, 4, 6 weeks
Method of measurement
Hamilton Depression Scale
Secondary outcomes
1
Description
side effects
Timepoint
1,2,4,6 weeks
Method of measurement
side effects checklist
Intervention groups
1
Description
Intervention group: Citalopram tab (max. dose 20mg/day) plus L-carnosine tab 400 mg/ twice per day) for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: Citalopram tab (max. dose 20mg/day) plus Placebo tab/ twice per day) for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatry Hospital
Full name of responsible person
Dr Mohammadreza Shalbafan
Street address
Tehran-Karaj 7 km, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۹۸۹۱۳۱۵۱
Phone
+98 21 4450 3395
Email
shalbafan.mr@iums.ac.ir
2
Recruitment center
Name of recruitment center
Tehran Psychiatry Institute
Full name of responsible person
Dr Mohammadreza Shalbafan
Street address
Mansoori St., Niayesh St.,Sattarkhan St., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1665
Fax
+98 21 6655 1665
Email
shalbafan.mr@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Shalbafan
Street address
Tehran-Karaj 7 km, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۹۸۹۱۳۱۵۱
Phone
+98 21 4452 5615
Fax
+98 21 6655 1665
Email
shalbafan.mr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Researchers
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Shalbafan
Position
Psychiatrist/ Assistant Prof.
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Iran Psychiatry Hospital, Tehran-Karaj Exp. way 7th Km, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۹۸۹۱۳۱۵۱
Phone
+98 21 4452 5615
Email
shalbafan.mr@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Shalbafan
Position
Psychiatrist/ Assistant Prof.
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Iran Psychiatry Hospital, Tehran-Karaj Exp. way 7th Km, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۹۸۹۱۳۱۵۱
Phone
+98 21 4452 5615
Fax
+98 21 6655 1665
Email
shalbafan.mr@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Shalbafan
Position
Psychiatrist/ Assistant Prof.
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Iran Psychiatry Hospital, Tehran-Karaj Exp. way 7th Km, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۹۸۹۱۳۱۵۱
Phone
+98 21 4452 5615
Fax
+98 21 6655 1665
Email
shalbafan.mr@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data about main outcome of study will be published
When the data will become available and for how long
2020
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
For scientific goals
From where data/document is obtainable
shalbafan.mr@iums.ac.ir
Dr Mohammadreza Shalbafan
What processes are involved for a request to access data/document