Effect of prebiotic supplementation in treatment of major depressive disorder

Not Applicable

Recruiting

• Conditions: Condition 1: Major depressive disorder, mild. Condition 2: Major depressive disorder, moderate.; Major depressive disorder, recurrent, mild; Major depressive disorder, recurrent, moderate

• Registration Number: IRCT20100209003320N14
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

Non-menopausal women aged 20-50 years
Body Mass Index (BMI) range: 30-40 Kg/m2
Suffering from mild to moderate depression based on DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) criteria, as diagnosed by a psychiatrist
Having received SSRI and SNRI drugs for at least 2 months
willingness to participate in the study

Exclusion Criteria

Pregnancy or lactation
Co-morbidity with other major psychological or neurological diseases including psychosis, multiple sclerosis (MS), bipolar disorder
Suffering from thyroid dysfunctions
Drug abuse
Smoking
A history of following particular diets
Using synthetic or herbal drugs for weight loss
Changes in medication protocol for major depressive disorder, during the study
Changes in type or dosage of any other medications during the study
Using fiber supplements or taking more than 25 grams of dietary fiber per day
Regular use of prebiotic or probiotic products or supplements, or antibiotic drugs during 2 months prior to the study or during the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxidative stress indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of serum levels of Total antioxidant capacity (TAC), malondialdehyde (MDA) and nitric oxide (NO) by spectrophotometry, serum isoprostane-F2 by ELISA, and arylesterase activity of paraoxonase enzyme by using phenyl acetate through spectrophotometry.;Depression severity. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Montgomery–Asberg Depression Rating Scale (MADRS).