Comparing the effectiveness of Agomelatine and Sertraline in the treatment of patients aged 18 to 65 years with major depression disorder
Design
A randomized clinical trials with parallel groups (Agomlatin and Sertraline), double-blind performed on 52 patients with major depression. Randomization will be done through block randomization method.
Settings and conduct
The place of the study is the clinic of Kargarnejad Psychiatric Hospital in Kashan. In this double blind study, both the patient and the assessor physician are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with major depressive disorder; Age of 18 to 65 years.
Non-inclusion criteria: pregnancy and lactation; History of bipolar and other psychiatric disorders; Patients with suicidal ideation; Use of other antidepressants; liver diseases.
Intervention groups
Intervention Group 1: Agomlatin is administered 25 to 50 mg daily for 8 weeks.
Intervention Group 2: Sertraline is prescribed 50 to 200 mg daily for 8 weeks.
Main outcome variables
Depression score in Hamilton's questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200407046977N1
Registration date:2020-07-07, 1399/04/17
Registration timing:retrospective
Last update:2020-07-07, 1399/04/17
Update count:0
Registration date
2020-07-07, 1399/04/17
Registrant information
Name
Marzieh Barati kariznoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5533 1274
Email address
marzieh_barati@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Agomelatine and Sertraline in the treatment of patients aged 18 to 65 years with major depression disorder
Public title
The effect of Agomellatin with sertraline in patients with major depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 65-18 years old
Patients with major depression based on the Hamiltonian scale and clinical interview based on the DSM5 criteria
Exclusion criteria:
Pregnancy and lactation
History of bipolar disorder and other psychiatric disorders
Use of other antidepressants
Patients with suicidal ideation
Liver disease or impaired liver function test
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Since it was possible that the members of each group could not be equal due to probability, using the quadruple block, all the probabilities of selecting individuals in groups were considered as AABB, ABAB, BAAB, BABA, BBAA, ABBA.Each group of four patients is randomly selected from one of the above blocks and individuals are assigned to one of groups A or B, respectively (Permuted block randomization method)
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications are placed in similar envelopes labeled A or B so that the patient is unaware of the prescribed medication. A psychiatrist visits the patient and prescribes medication, and another psychiatrist who is unaware of the treatment assigned to the patient evaluates the treatment results with Hamilton scales.
Placebo
Not used
Assignment
Parallel
Other design features
The study questinnaire was developed in 1960 by Hamilton to assess the severity of depression by a therapist. A standard, semi-structured questionnaire for assessing depression includes 24 questions and scores from 0 to 50. The questionnaire measures various aspects of depression (behavioral, physical, cognitive, emotional, emotional, hypochondriac, sexual issues, suicide, and sleep disorders). Grades 13-8 are mild depression, 18-18 are moderate depression, 19-22 are severe, and 23 and above are very severe. A score below 7 indicates no depression. This questionnaire has a satisfactory validity and very good reliability (9). In 2000, Gharaei, Houshang Mehryar and Mehrabi reported the reliability coefficient of this scale using 0.85 and 0.89 retesting methods.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kargarnejad Hospital; Kashan University of Medical Sciences; Ghotbe Ravandi bulevard
City
Kashan
Province
Isfehan
Postal code
8715973446
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.139
Health conditions studied
1
Description of health condition studied
Major depression disorder
ICD-10 code
F33.9
ICD-10 code description
Major depressive disorder, recurrent, unspecified
Primary outcomes
1
Description
Depression score in the Hamilton questionnaire
Timepoint
At the beginning of the study (week 0) and weeks 2, 4, 6, and 8 after the intervention
Method of measurement
Hamilton Depression Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: Prescribing Agomlatin from Tadbir Kala Company with a daily dose of 25 to 50 mg for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: Sertralin tablet 50 mg/ Daily, manufactured by Abidi co.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Kargarnejad psychiatric hospital
Full name of responsible person
Dr. Afshin Ahmadvand
Street address
Kargarnejad hospital; Kashan University of Medical Sciences; Ghotbe Ravandi bulevard
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
marzieh_barati@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Kargarnejad hospital; Kashan University of Medical Sciences; Ghotbe Ravandi bulevard
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
marzieh_barati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Afshin Ahmadvand
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Kargarnejad hospital; Kashan University of Medical Sciences; Ghotbe Ravandi bulevard
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
ahmadvand_a@kaums
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Afshin Ahmadvand
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Kargarnejad hospital; Kashan University of Medical Sciences; Ghotbe Ravandi bulevard
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
ahmadvand_a@kaums
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Afshin Ahmadvand
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Kargarnejad hospital; Kashan University of Medical Sciences; Ghotbe Ravandi bulevard
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
ahmadvand_a@kaums
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