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

Phase 1

Completed

• Conditions: Depressive Disorder; Depressive Disorder, Major Depressive Disorder
• Interventions: Drug: The probiotic supplement (Moodamin capsuls); Drug: Placebo

• Registration Number: NCT06790823
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-15
• Primary Completion: 2023-04-12
• Study Completion: 2023-04-12
• Status Verified: 2025-01
• Study First Submitted: 2025-01-18
• Study First Submitted QC: 2025-01-18
• Last Update Submitted: 2025-01-18
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	The probiotic supplement (Moodamin capsuls)	Participants were asked to take two capsules per day for four weeks, preferably before a meal.
Placebo	Placebo	Participants were asked to take two placebo capsules per day for four weeks, preferably before a meal.

Primary Outcome Measures

Name	Time	Method
The Beck Depression Severity	4 weeks	The Beck Depression Severity Questionnaire used to assess the severity of depressive symptoms in participants.

Trial Locations

Locations (1)

Shiraz University of Medical Sciences, Shiraz, Iran; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of