Comparison of the efficacy of omega-3 as an adjunctive therapy of sertraline and venlafaxine in improving symptoms of major depressive disorder : A Double-blind , placebo controlled trial
Determining the effectiveness of omega-3 combination therapy with sertraline and venlafaxine on the symptoms of major depressive disorder
Design
Double-blind clinical trial, with two intervention groups and two control groups, randomized
Settings and conduct
They are randomly divided into four groups of 16 people. The first group is a combination of 25 mg of sertraline daily for the first 4 days and then 50 mg daily to complete the course of treatment with one gram of omega-3 daily, the second group 37.5 ml. Warm venlafaxine daily for the first 4 days and then 70 mg daily to complete the course of treatment with one gram of omega-3 daily, the third group 25 mg of sertraline daily for the first 4 days and then 50 mg daily to complete the course of treatment with The placebo and the fourth group combine 37.5 mg of venlafaxine daily for the first 4 days and then 70 mg daily until single. They will use the course of treatment with placebo.
They are tested by Hamilton's questionnaire before and 4 weeks after treatment and demographic information is collected.All stages of the study will be performed in the psychiatric clinic of Imam Hossein Hospital.
Participants/Inclusion and exclusion criteria
Having DSM-V diagnostic criteria for major depressive disorder with clinical diagnosis of psychiatrist
Earning a score higher than 7 based on Hamilton's Questionnaire (HAM-D)
Obtain informed consent from the patient
Age between 18 and 60 years
There is no psycho-manifestation
Intervention groups
Group 1: Receive 50 mg sertraline + 2 gr of omega-3
Group 2: Receive 75 mg venlafaxine + 2 gr of omega-3
Group 3: Receive 50 mg sertraline + placebo
Group 4: Receive 75 mg venlafaxine + placebo
Comparison of the efficacy of omega-3 as an adjunctive therapy of sertraline and venlafaxine in improving symptoms of major depressive disorder : A Double-blind , placebo controlled trial
Public title
omega3 in depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having DSM-V diagnostic criteria for major depressive disorder with clinical diagnosis of psychiatrist
Earning a score higher than 7 based on Hamilton's Questionnaire (HAM-D)
Obtain informed consent from the patient
Age between 18 and 60 years
There is no psycho-manifestation
Exclusion criteria:
Drug abuse and drug abuse other than nicotine and caffeine
IQ less than 70
There is another psychiatric disorder in the diagnostic axis one
The presence of a medical condition (especially liver disease, cardiovascular disease and hypertension) or significant neurology
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
After completing the course of treatment and recording the results, matching the delivery codes and the patient's specific code is determined by what treatment the patient received.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be referred to a designated pharmacy after an examination by a psychiatrist and will receive information and receive a specific code, and will be randomized by the provider of the medication, placebo or pills containing omega-3s.
After completing the course of treatment and recording the results, matching the delivery codes and the patient's specific code is determined by what treatment the patient received.
The patient and psychiatrist are not on the verge of being given a placebo or an effective pill
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Deputy of Research and Technology,Alley Safariyan,45 meters Golshahr,Karaj,Alborz Province
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2019-01-14, 1397/10/24
Ethics committee reference number
IR.ABZUMS.REC.1397.162
Health conditions studied
1
Description of health condition studied
Major Depression
ICD-10 code
F32.9
ICD-10 code description
Depression NOSDepressive disorder NOS
Primary outcomes
1
Description
Hamilton questionnaire score
Timepoint
Before treatment and 4 weeks after treatment
Method of measurement
Hamilton questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 mg Sertraline daily plus two grams of Omega 3 daily
Category
Treatment - Drugs
2
Description
Intervention group: 75 mg of venlafaxine daily plus two grams of omega 3 daily
Category
Treatment - Drugs
3
Description
Control group:50 mg sertraline daily with placebo
Category
Placebo
4
Description
Control group: 75 mg daily venlafaxine with placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Mohammad Ahadi Fard Moghadam
Street address
104 Street,Mohammad shahr,
City
Karaj
Province
Alborz
Postal code
4356968526
Phone
+98 26 3622 0118
Email
Imamhosseinhospital@abzums.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz Univesity of Medical Sience
Full name of responsible person
Shahroz Yazdani
Street address
No7 , Safaee ave , 45m Golshar steer
City
Karaj
Province
Alborz
Postal code
2365987456
Phone
+98 26 3622 0118
Email
reserach@abzums.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz Univesity of Medical Sience
Proportion provided by this source
50
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
Alborz Univesity of Medical Science
Full name of responsible person
Mohammad Ahadi Fard Moghadam
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Alborz university of medical science,Boo Ali street,karaj
City
Karaj
Province
Alborz
Postal code
1234567895
Phone
+98 26 3677 3900
Fax
Email
mohammadafm72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz Univesity of Medical science
Full name of responsible person
Mohammad Ahadi Fard Moghadam
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Alborz university of medical sience,Boo Ali street,karaj
City
Karaj
Province
Alborz
Postal code
1234567895
Phone
+98 26 3677 3900
Fax
Email
mohammadafm72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Ahadi Fard Moghadam
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Alborz University of Medical science,Boo Ali street,karaj
City
Karaj
Province
Alborz
Postal code
1234567895
Phone
+98 26 3677 3900
Fax
Email
mohammadafm72@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not 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