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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
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
1
-
Sponsor
-
-
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
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
-
by E mail
-
Comments
-