The aim of this study is to determine the effect of probiotic capsule supplementation on severity depression among patients with major depressive disorder under treatment with citalopram. Study design: Randomized double-blinded controlled clinical trial. Inclusion Criteria: Patients with major depressive according to DSM-IV-TR criteria, aged 20 to50 years, the least score 12 on BDI –II scoring system. Exclusion Criteria: Pregnancy, alcohol and drug abuse within 6 months prior to the start of the project, psychosis, mental retardation, depression caused by physical illness or drugs and substances, any type of severe, chronic physical illness, chronic physical illness and any extreme and severe mental disorders (suicidal ideation, psychotic symptoms, symptoms of manic phase, etc) will be excluded. Population and sample size: 70 patients with major depressive disorder of eligible and referred to Karganejad hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either the probiotic capsule (intervention group: n=35) or placebo capsule (control group: n=35). Fasting blood samples will be taken at baseline and after 8-wk intervention. Intervention: 8 weeks (July 12, 2014-september 12, 2014). Outcomes: Fasting plasma glucose, serum insulin, hs-CRP, insulin resistance, lipid profiles (total cholesterol, HDL-cholesterol and triglycerides) will be measured at the beginning and end of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060717993N1
Registration date:2014-11-04, 1393/08/13
Registration timing:retrospective
Last update:
Update count:1
Registration date
2014-11-04, 1393/08/13
Registrant information
Name
Zahra Kashanipoor
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 1112
Email address
zkashani@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
TAK GENE ZIST Co , Tehran , Iran. Kashan University of Medical Sciences.
Expected recruitment start date
2014-07-12, 1393/04/21
Expected recruitment end date
2014-09-12, 1393/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic capsule supplementation on severity depression among patients with major depressive disorder under treatment with citalopram
Public title
The effect of probiotic capsule supplementation on severity depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with major depressive according to DSM-IV-TR criteria; aged20 to 50 years; the least score 12 on BDI –II scoring system.
Exclusion Criteria: Alcohol consumption and drug abuse during the 6 months before the start of intervention; pregnant; psychotic symptoms; mental retardation; depression caused by physical diseases or taking medications and substances; any type of severe and chronic physical diseases; subjects with acute and severe medical illnesses; the incidence of any severe mental disorder (suicidal thoughts, psychotic symptoms, symptoms of mania phase, etc).
Age
From 20 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan , 5th of Qotb –e Ravandi Blvd
City
Kashan
Postal code
Approval date
2014-06-09, 1393/03/19
Ethics committee reference number
1234
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Triglyceride
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
2
Description
Cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
3
Description
severity depression
Timepoint
One day before the start of the intervention (first visit: Baseline study), the end of the second week (second visit of drug side effects), the end of the fourth week (third visit) and at the end of the sixth week (fourth visit) and at the end of the eighth week (End-of-trial) will visit .
Method of measurement
at each visit to the BDI-II testing will be completed.