Determining the effect of adding agomelatine to Escitalopram in the treatment of major depressive disorder
Design
In this double-blind phase 3 clinical trial study, 70 patients with major depressive disorder were distributed in to two groups of 35 by using simple random allocation method.
Settings and conduct
This clinical trial study was performed in 1400 in psychiatric clinics affiliated to Shahid Sadoughi University of Medical Sciences in Yazd. The study is a double-blind and patients and the person evaluating the outcome of treatment are unaware of the type of drug received.
Participants/Inclusion and exclusion criteria
In this study, patients with major depressive disorder who agree to participate in the study and are in the age range of 18 to 65 years are included in the study. Patients with a history of underlying disease, drug addiction and illiteracy are not included in the study.
Intervention groups
70 patients with major depressive disorder are divided into two groups of 35 patients. In the first group, 25-50 mg of oral Agomelatine was given as a single daily dose and 10-20 mg of oral Escitalopram as a single daily dose for 12 weeks and in the second group, 10-20 mg of oral Escitalopram as a single daily dose. It is given with a placebo that is similar to Agomelatine at the same dose and duration.
Main outcome variables
Treatment of major depressive disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N52
Registration date:2021-02-24, 1399/12/06
Registration timing:prospective
Last update:2021-02-24, 1399/12/06
Update count:0
Registration date
2021-02-24, 1399/12/06
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding Agomelatine to Escitalopram in the treatment of major depressive disorder
Public title
The effect of adding Agomelatine to Escitalopram in the treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Major Depressive Disorder
Patient consent to participate in the study
range age between 18-65 years
Minimum literacy
Has suitable conditions for completing the questionnaire
Exclusion criteria:
Drug addiction
Having medical and underlying disease
Major changes in diet regimen in recent months
Existence of verbal and hearing problems
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation patients between two groups will be done by simple random allocation method. To do this, 70 cards with 35 letters A on them and 35 letters B on the other 35 were prepared and placed in a box and shuffled well. Patients are initially asked to take a card out of the box. Depending on the letter written on the card, patients enter the first group (letter A) or the second group (letter B).
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding is that patients are unaware of the type of medication they are receiving. The drug is prescribed by the researcher, but the outcome of the treatment is reviewed by an experienced psychiatrist who is unaware of the type of medication the patient is receiving.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ُShahid Sadoughi University of Medical Sciences
Street address
Research faculty, Shahid sadoughi University of medical sciences, shohadaye gomnam street
City
Yazd
Province
Yazd
Postal code
8434193474
Approval date
2019-11-21, 1398/08/30
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.305
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32:
ICD-10 code description
Major Depressive Disorder
Primary outcomes
1
Description
treatment of Major Depressive Disorder
Timepoint
Every month
Method of measurement
Hamilton questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Receive 25-50 mg oral Agomelatine of Abidi Pharmaceutical Company as a single daily dose and 10-20 mg of oral Escitalopram made by abidi Pharmaceutical Company as a single daily dose for 12 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Receive 10-20 mg of oral Escitalopram in a single daily dose with placebo, which is prepared similar to agomelatine and is given at the same dose and duration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychatry clinic, Shahid Sadoughi hospital
Full name of responsible person
Hosein Azadi
Street address
Psychiatry clinic, Shahid Sadoughi hospital, Shohadaye gomnam street
City
Yazd
Province
Yazd
Postal code
8434193474
Phone
+98 31 3669 2174
Email
reza.bidaki111@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Research faculty, Shahid Sadoughi university of Medical Sciences, Shohadaye gomnam street
City
Yazd
Province
Yazd
Postal code
8434193474
Phone
+98 35 3726 3733
Email
M_mirzaei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Reza Bidaki
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychology, Shahid sadoughi hospital, Shohadaye gomnam street
City
Yazd
Province
Yazd
Postal code
8434193474
Phone
+98 35 3726 3733
Email
reza.bidaki111@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Reza Bidaki
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychology, Shahid Sadoughi hospital, Shohadaye gomnam street
City
Yazd
Province
Yazd
Postal code
8434193474
Phone
098 35 37263733
Email
reza.bidaki111@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research faculty, Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
al.mehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The plan belongs to a government agency and cannot be shared