curcumin effect on cognitive and inflammatory indices in patients with major depressive disorder
Design
Double blind randomized clinical trial, with two parallel arms each consists of 60 patients, simple randomized
Settings and conduct
all self referral clients of hoshiar psychology clinics of Tehran city received clinical diagnosis of major depression and were interested, screened according to criterion of study.
they located in homogenized gender groups in case or contol arm by simple randomization
Participants/Inclusion and exclusion criteria
age between 18 to 55
diagnosis of major depressive disorder according to DSM5 criteria
able to read, write and speak eloquent in Persian
no history of substance abuse and cigarette smoking
no history of regular use of NSAIDs and celecoxib
no history of psychotropic medications during last three years
no history of herbal, nutritional or medical supplement during last three years
BMI less than 35
no history of CNS affecting conditions (seizure, head trauma, multiple sclerosis)
no history of other psychiatric disorders
no history of any systemic condition
no history of ECT therapy
no history of infection during last month
no suicidal idea
no hormonal disturbances
no need for hospitalization
Intervention groups
both case and control groups receiving 50 mg of sertraline. in addition 1g curcumin administrated in case group , control group received placebo.
Main outcome variables
cognitive function as speed processing, working memory and set shifting
inflammatory indices of IL1beta, Il-6,hs-CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200607047672N1
Registration date:2020-12-27, 1399/10/07
Registration timing:retrospective
Last update:2020-12-27, 1399/10/07
Update count:0
Registration date
2020-12-27, 1399/10/07
Registrant information
Name
Zeynab Ali madadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8602 7558
Email address
sa.azamy@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2020-03-04, 1398/12/14
Actual recruitment start date
2018-08-09, 1397/05/18
Actual recruitment end date
2020-03-04, 1398/12/14
Trial completion date
2020-06-03, 1399/03/14
Scientific title
Effect of curcumin on cognitive function and inflammatory index in people affected by major depression
Public title
Effect of curcumin in depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of major depression by psychiatrist
no history of drug abuse
no history of endocrinological disorders
no history of immune dysfunction disorders
no history of other CNS disorders
not obese
not being on any type of dieting
no suicidal idea
no psychosis
not using antidepressant medications for last three months
not using anti inflammatory medications
not using unprescribed medicine
speaking Persian fluently
ability to write Persian
not pregnant
Exclusion criteria:
history of drug abuse
endocrinological disorders
immune dysfunction disorders
other CNS disorders
obesity
using a special form of diet
suicide idea
psychosis
using antidepressant medications for last three months
using anti inflammatory medications
using unprescribed medicine
pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Among the patients with MDD referred to medical centers, 120 people were selected by criterion sampling method based on inclusion and exclusion criteria and were randomly assigned to two groups A and B based on a table of random numbers. Then A and B groups were assigned to be curcumin and active control groups randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principal investigators, paraclinical colleagues of the project, data analysts did not know which group A or B was the test or control.
Both groups were treated with sertraline. In the control group, placebo was used, which was completely similar in color, weight and size to the curcumin capsule.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of medical sciences
Street address
n13, hamid Ave,Shariatii St, north to motahari St
City
Tehran
Province
Tehran
Postal code
1639666355
Approval date
2017-05-04, 1396/02/14
Ethics committee reference number
IR.IUMS.REC.1397.1167
Health conditions studied
1
Description of health condition studied
Major Depression
ICD-10 code
F33
ICD-10 code description
Major depressive disorder, recurrent
Primary outcomes
1
Description
speed processing time in trail making task A
Timepoint
At beginning, after 6 weeks and12 weeks
Method of measurement
trail making task A
2
Description
speed processing time in trail making task B
Timepoint
At beginning, after 6 weeks and12 weeks
Method of measurement
trail making task B
3
Description
executive function score on verbal fluency task
Timepoint
At beginning, after 6 weeks and12 weeks
Method of measurement
verbal fluency task
4
Description
executive function score on Wisconsin sorting test
Timepoint
At beginning, after 6 weeks and12 weeks
Method of measurement
Wisconsin sorting test
5
Description
serum level of interleukin 1 beta
Timepoint
At the beginning and week 12
Method of measurement
Serum test, Enzyme linked Immuno Assay ,ELISA
6
Description
serum level of interleukin 6
Timepoint
At the beginning and week 12
Method of measurement
Serum test, Enzyme linked Immuno Assay ,ELISA
7
Description
serum level of high sensitivity C reactive protein
Timepoint
At the beginning and week 12
Method of measurement
Serum test, Enzyme linked Immuno Assay ,ELISA
8
Description
executive function score on Tower of London Test
Timepoint
At beginning, after 6 weeks and12 weeks
Method of measurement
Tower of London Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sertraline 50 mg and curcumin 1000 mg so that in the first four days of sertraline 25 mg, then 50 mg sertraline until the end of the intervention. Curcumin at a dose of 1000 mg daily was added to the standard treatment in divided doses of 500 mg in the morning and at noon with water.
Category
Treatment - Drugs
2
Description
Control group: sertraline 50 mg and placebo. In the first four days, sertraline received 25 mg, then 50 mg sertraline until the end of the intervention. Placebo (roasted rice powder) at a dose of 1000 mg per day, divided into It was added to the standard treatment in two doses of 500 mg in the morning and at noon with water.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
hoshiar psychological clininc
Full name of responsible person
Saeed Azami
Street address
n2 Bahar building masud ave ,north sheykhbahaii
City
Tehran
Province
Tehran
Postal code
1995833867
Phone
+98 21 8861 2962
Fax
Email
Sasa.azamy@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shima Jazayeri
Street address
Iran University of medical science, hemmat Expressway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
Jazayeri.sh@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
20
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
Iran University of Medical Sciences
Full name of responsible person
Zeynab Ali madadi
Position
psychiatrist
Latest degree
Specialist
Other areas of specialty/work
nutrition and psychiatry
Street address
n13 hamid avn, shariati st
City
Tehran
Province
Tehran
Postal code
1639666355
Phone
+98 21 8862 4617
Email
zeinabalimadadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zeynab Alimadadi
Position
psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
n13 hamid ave, shariatii st
City
Tehran
Province
Tehran
Postal code
1639666355
Phone
+98 21 8862 4617
Email
zeinabalimadadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
zeynab ali madadi
Position
psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
n13 hamid ave, shariatii st
City
Tehran
Province
Tehran
Postal code
1639666355
Phone
+98 21 8862 4617
Email
zeinabalimadadi@gmail.com
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after individuals become unidentifiable
When the data will become available and for how long
available after 6 months of publication
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Academic and scientific research cases
From where data/document is obtainable
Dr Zeynab Ali madadi
zeinabalimadadi@gmail.com
or
hoshiar psychological center
Dr Aaeed Azami
sa.azamy@gmail.com
00989124758909
What processes are involved for a request to access data/document
Send email to the responsible author.
Authentication documents certified by the applicant or the relevant research center must be sent.
Specify how and with what intention the information will be used.
according to this instruction, data access, treatment protocol, data analysis map and clinical study report will be available within two working weeks.