Comparison of the effectiveness of three drugs agomelatine, bupropion and sertraline in the treatment of non psychotic major depressive disorder: A randomized double blind clinical trial
Determining the effectiveness of three drugs agomelatine, bupropion and sertraline in the treatment of non-psychotic major depressive disorder
Design
Clinical trial without control group, with parallel groups, double-blind, randomized, 90 patients with 6 block size will be randomly assigned to three groups of 33 people.
Settings and conduct
The study population was patients aged 20-60 years referred to a psychiatric clinic and patients admitted to the psychiatric ward. Patients will be randomly divided into 3 intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 20-60 years; Major Depressive Disorder (Based on the diagnosis of a psychiatrist and a psychiatric assistant with a structured clinical interview based on the DSM-5)
Exclusion criteria: substance abuse; Hypothyroidism; Severe anemia;Pregnancy and lactation; Epilepsy; Mental retardation
Intervention groups
Intervention group 1: Patients in the agomelatine group (Tadbir Kalay Jam Company) will initially receive 25 mg of the drug daily at bedtime for two weeks, and patients who do not show improvement with 25 mg per day will be increased to 50 mg per day. (Depending on the patient's response, it is possible to increase the dose to a maximum of 50 mg).
Intervention group 2: Patients in the sertraline group (Sobhan company) will receive 50 mg of the drug every morning (depending on the patient's response, the dose can be increased to a maximum of 200 mg).
Intervention group 3: Patients in the bupropion group (Abidi company) will receive 75 mg twice a day (depending on the patient's response, the dose can be increased to a maximum of 450 mg).
Main outcome variables
patient´s depressive condition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190525043700N4
Registration date:2021-10-25, 1400/08/03
Registration timing:registered_while_recruiting
Last update:2021-10-25, 1400/08/03
Update count:0
Registration date
2021-10-25, 1400/08/03
Registrant information
Name
Romina Hamzehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
r.hamzehpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of three drugs agomelatine, bupropion and sertraline in the treatment of non psychotic major depressive disorder: A randomized double blind clinical trial
Public title
Efficacy of three drugs agomelatine, bupropion and sertraline in the treatment of major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-60 years
Major Depressive Disorder (Based on the diagnosis of a psychiatrist and a psychiatric assistant with a structured clinical interview based on the DSM-5)
Exclusion criteria:
Drug abuse
Hypothyroidism
Severe anemia
Pregnancy and lactation
Epilepsy
Mental retardation
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to three groups of 30 using 6 blocks in a ratio of 1: 1: 1. Randomization will be performed using a randomization table (computer randomization program). The randomization table will be created by a statistical expert and will be provided to the researchers. The patient and the researcher (evaluator) will not know how to classify and the type of drug received and only the treating physician is aware of the type of drug.
Blinding (investigator's opinion)
Double blinded
Blinding description
Agomelatine (Tadbir Kalay Jam Company), Sertraline (Sobhan Company) and Bupropion (Obaidi Company) will be poured into separate capsules in the form of crushed tablets. The shape, color, size and packaging of all medicines are exactly the same.Consecutive opaque numbered envelopes were used to conceal the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2021-10-06, 1400/07/14
Ethics committee reference number
IR.MUBABOL.HRI.REC.1400.086
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
Primary outcomes
1
Description
patient´s depressive condition
Timepoint
Before the intervention (first visit), end of the second week (second visit), end of the fourth week (third visit), end of the eighth week (fourth visit)
Method of measurement
Hamilton Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:Patients in the agomelatine group (Tadbir Kalay Jam Company) will initially receive 25 mg of the drug daily at bedtime for two weeks, and patients who do not show improvement with 25 mg per day will be increased to 50 mg per day. (Depending on the patient's response, it is possible to increase the dose to a maximum of 50 mg).
Category
Treatment - Drugs
2
Description
Intervention group2: Patients in the sertraline group (Sobhan company) will receive 50 mg of the drug every morning (depending on the patient's response, the dose can be increased to a maximum of 200 mg).
Category
Treatment - Drugs
3
Description
Intervention group3: Patients in the bupropion group (Abidi company) will receive 75 mg twice a day (depending on the patient's response, the dose can be increased to a maximum of 450 mg).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahyanezhed Haspital
Full name of responsible person
Romina Hamzehpour
Street address
Shahid Mostafa Khomeini St., Modarres St
City
babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3222 5035
Email
r.hamzehpour@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Romina Hamzehpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 9595
Email
r.hamzehpour@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Romina Hamzehpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 9595
Email
r.hamzehpour@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Romina Hamzehpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 9595
Email
r.hamzehpour@mubabol.ac.ir
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
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available