Effect of Probiotic Supplement on Improvement of Depressive Symptoms in Patients With Substance-Induced Depressive Disorder

This study investigates the potential of probiotics as a therapeutic intervention for Substance-Induced Depressive Disorder (SIDD). The primary question the study aims to answer is: Can a four-week course of probiotics improve depressive symptoms and alter immune markers in patients diagnosed with SIDD, compared to a placebo?

The study uses a double-blind, placebo-controlled, randomized clinical trial design with 40 participants to explore this question by measuring clinical outcomes using BDI and HAM-A and immunological markers.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Disorder Depressive Disorder, Major Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shiraz University of Medical Sciences, Shiraz, Iran

Shiraz, Fars, 71356-44144, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and females, aged between 18 and 70 years
Diagnosis of Substance-Induced Depressive Disorder as per DSM-5 criteria
Absence of significant internal diseases as per exclusion criteria

Exclusion criteria

Pregnant or lactating
Patients who for any reason cannot comply with adequate follow-up

Treatment and study plan

The probiotic supplement (Moodamin capsuls)

Drug

The probiotic supplement (Moodamin capsuls) provided from Amin pharmacytical company, Iran, was freeze-dried containing Lactobacillus helveticus and Bifidobacterium Longum bacteria at a dose of 2.682 × CFU and 0.318 × CFU each capsule, respectively.Excipients include xylitol, maltodextrin, plum flavor, and malic acid.

Placebo

Drug

The probiotic supplement (Moodamin capsuls) provided from Amin pharmacytical company, Iran, was freeze-dried containing Lactobacillus helveticus and Bifidobacterium Longum bacteria at a dose of 2.682 × CFU and 0.318 × CFU each capsule, respectively. Excipients include xylitol, maltodextrin, plum flavor, and malic acid. A placebo product used for the control group was made up of excipients only.

Primary outcomes

The Beck Depression Severity

Time frame: 4 weeks

The Beck Depression Severity Questionnaire used to assess the severity of depressive symptoms in participants.

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

Effect of Probiotic Supplement on Improvement of Depressive Symptoms in Patients With Substance-Induced Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jan 24, 2025
Registry last updated: Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting