Evaluation of the efficacy of gemfibrozil as an adjunct therapy in improving the symptoms of major depressive disorder; A double- blind, placebo-controlled trial
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Protocol summary
The participants will be randomly allocated into two groups. Intervention group(20 persons) will receive gemfibrozil (200 mg per day) and sertraline ( 100 mg per day) for 8 weeks and control group ( 20 persons) will receive sertraline ( 100 mg per day) for 8 weeks.
The participants will be randomly allocated into two groups. Intervention group(20 persons) will receive gemfibrozil (300 mg per day) and sertraline ( 100 mg per day) for 8 weeks and control group ( 20 persons) will receive sertraline ( 100 mg per day) for 8 weeks.
The participants will be randomly allocated into two groups. Intervention group(20 persons) will receive gemfibrozil (200300 mg per day) and sertraline ( 100 mg per day) for 8 weeks and control group ( 20 persons) will receive sertraline ( 100 mg per day) for 8 weeks.
شرکت کنندگان به صورت تصادفی به دو گروه تقسیم می شوند. گروه مداخله( 20 نفر) جم فیبروزیل( 200 میلیگرم در روز ) و سرترالین (روزانه 100 میلیگرم ) برای 8 هفته دریافت خواهند کرد. گروه کنترل (20 نفر) برای هشت هفته سرترالین (100 میلیگرم در روز) و دارونما دریافت خواهند کرد.
شرکت کنندگان به صورت تصادفی به دو گروه تقسیم می شوند. گروه مداخله( 20 نفر) جم فیبروزیل( 300 میلیگرم در روز ) و سرترالین (روزانه 100 میلیگرم ) برای 8 هفته دریافت خواهند کرد. گروه کنترل (20 نفر) برای هشت هفته سرترالین (100 میلیگرم در روز) و دارونما دریافت خواهند کرد.
شرکت کنندگان به صورت تصادفی به دو گروه تقسیم می شوند. گروه مداخله( 20 نفر) جم فیبروزیل( 200300 میلیگرم در روز ) و سرترالین (روزانه 100 میلیگرم ) برای 8 هفته دریافت خواهند کرد. گروه کنترل (20 نفر) برای هشت هفته سرترالین (100 میلیگرم در روز) و دارونما دریافت خواهند کرد.
General information
empty
change the dosage
change the dosage
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تغییر دوز
تغییر دوز
Intervention groups
#1
Intervention group: tablet sertralin 100 mg/day plus Capsule gemfibrozil 200 mg per day as intervention group for 8 weeks
Intervention group: tablet sertralin 100 mg/day plus Capsule gemfibrozil 300 mg per day as intervention group for 8 weeks
Intervention group: tablet sertralin 100 mg/day plus Capsule gemfibrozil 200300 mg per day as intervention group for 8 weeks
گروه مداخله: قرص سرترالین 100 میلیگرم در روز به علاوه جم فیبروزیل 200 میلیگرم در روز به عنوان گروه مداخله برای 8 هفته
گروه مداخله: قرص سرترالین 100 میلیگرم در روز به علاوه جم فیبروزیل 300 میلیگرم در روز به عنوان گروه مداخله برای 8 هفته
گروه مداخله: قرص سرترالین 100 میلیگرم در روز به علاوه جم فیبروزیل 200300 میلیگرم در روز به عنوان گروه مداخله برای 8 هفته
Protocol summary
Study aim
The objective of this study is to assess the efficacy of Gemfibrozil in the treatment of MDD
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
The study will be conducted among adults with major depressive disorder attending Roozbeh Hospital and Imam-Hossein Hospital(in Karaj).
Participants/Inclusion and exclusion criteria
Inclusion criteria: presence of Major Depressive Disorder based on DSM-5 criteria; baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 22
Exclusion criteria: presence of psychosis, any other mental disorder; substance dependence(except for Nicotine and caffeine); IQ lower than 70;significant neurologic or medical disease; history of cholelithiasis; receiving Warfarin; receiving Insulin; receiving Statins; receiving Niacin
Intervention groups
The participants will be randomly allocated into two groups. Intervention group(20 persons) will receive gemfibrozil (300 mg per day) and sertraline ( 100 mg per day) for 8 weeks and control group ( 20 persons) will receive sertraline ( 100 mg per day) for 8 weeks.
Main outcome variables
Severity of depression
General information
Reason for update
change the dosage
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N119
Registration date:2019-03-17, 1397/12/26
Registration timing:prospective
Last update:2020-03-27, 1399/01/08
Update count:1
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-05, 1398/01/16
Expected recruitment end date
2021-04-04, 1400/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of gemfibrozil as an adjunct therapy in improving the symptoms of major depressive disorder; A double- blind, placebo-controlled trial
Public title
Evaluation of the efficacy of gemfibrozil as an adjunct therapy in improving the symptoms of major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of Major Depressive Disorder based on DSM-5 criteria
Baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 22
Age between 18 to 60 years
Exclusion criteria:
Presence of psychosis
Substanse use disorder except for nicotine and caffeine
IQ lower than 70
Any other mental disorder
Any significant neurologic or medical disease(advanced renal disease, CKD, hepatic disease, cardiovascular disease)
history of cholelithiasis
Receiving Warfarin
Recieving Insulin
Receiving statins
Receiving niacin
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random permuted block
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, clinicians and outcome raters will be blind regarding grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-03-08, 1397/12/17
Ethics committee reference number
IR.TUMS.VCR.REC.1397.880
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32.2
ICD-10 code description
Major depressive disorder, single episode, severe without psychotic features
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline and weeks 2,4 and 8
Method of measurement
by Hamiltion Depression Rating Scale 17-Item
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: tablet sertralin 100 mg/day plus Capsule gemfibrozil 300 mg per day as intervention group for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: tablet sertralin 100 mg/day plus Capsule placebo as control group for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
Roozbeh Hospital , South Kargar Sreeet
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr Atefeh Zandi Far
Street address
Imam Hossein Hospital, 104th Street, Imam Khomeini Blvd., Mohammad Shahr
City
Tehran
Province
Tehran
Postal code
3184669519
Phone
+98 26 3620 9063
Email
zandifar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street,
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacologyا
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2021 to 2026
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
by citing the resourse
From where data/document is obtainable
Professor Shahin Akhondzadeh
What processes are involved for a request to access data/document