Effects of Hesperidin on serum homocysteine, cortisol and tryptophan kynurenine pathway in patients with major depressive disorder
Design
double blind randomized controlled trial
Settings and conduct
forty eight patients with major depression aged 18 to 65 years will be referred to Ziaeian hospital. They will randomly be allocated to groups, daily Hesperidin supplement or placebo daily for 8 weeks.To measure serum level of cortisol, homocysteine, tryptophan and kynurenine, 10 ml of venous blood will be collected after 10-12 hours of fasting at the beginning and at the end of the study.
Participants/Inclusion and exclusion criteria
Participants: Patients with major depression aged 18 to 65 years.
inclusion criteria:having physical health based on history, no regular use of any supplements more than twice a week, two months prior the intervention, No use of drugs and any antidepressant, no citrus consumption more than 2 units per day, lack of thoughts of death and suicide, lack of mental illness except anxiety
Exit criteria: Dissatisfaction of patients to continue cooperation, pregnancy and lactation, obtaining each non-compliance criterion.
Intervention groups
Intervention group: Received one capsule of 500 mg hesperidine + sertraline daily
Control group:Received one capsule of 500 mg placebo + sertraline
Main outcome variables
Serum level of cortisol, tryptophan, homocysteine, kynurenine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090901002394N40
Registration date:2018-12-18, 1397/09/27
Registration timing:registered_while_recruiting
Last update:2018-12-18, 1397/09/27
Update count:0
Registration date
2018-12-18, 1397/09/27
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Hesperidin on serum homocysteine, cortisol and tryptophan kynurenine pathway in major depressive disorder
Public title
effect of hesperidin on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate
Clinical diagnosis of major depressive disorder; A score ≥15 in the 17-item Hamilton Depression Rating Scale;
Age 18 – 65 years;
Good health status based on medical history
No dietary supplement use during the previous two months
No antidepressant or steroid use
Absence of benign hormone-sensitive tumors in the ovary, uterus, breast, prostate
Not having thoughts about death and suicide
Not having any mental illness except anxiety
Do not eat citrus more than two units per day
Exclusion criteria:
Pregnancy and lactation
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:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be divided into two groups: intervention and placebo (stratified randomization) Based on age (18-40 40-65)
Using 4-way permutation blocks and select blocks based on random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo and supplements will be similar in appearance and coded by someone other than the researcher.
All investigators, study staff, and participants will be unaware of the allocations. The randomization code will be broken only when the statistical model of the primary and secondary results will be completed.
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
Shahid Hemmat Highway, next to Milad Hospital, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-03-01, 1396/12/10
Ethics committee reference number
IR.IUMS.REC 1396.9511468005
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32.3
ICD-10 code description
Major depressive disorder, single episode, severe with psychotic features