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

NCT06790823 | Completed Phase 1 DMC

• 1 other identifier: IR.SUMS.REC.1400.442
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Depressive Disorder, Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• The Beck Depression Severity

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

  4 weeks

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Participants were asked to take two capsules per day for four weeks, preferably before a meal.

Drug: The probiotic supplement (Moodamin capsuls)

Placebo

PLACEBO COMPARATOR

Participants were asked to take two placebo capsules per day for four weeks, preferably before a meal.

Drug: Placebo

Interventions

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.

Probiotic

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, aged between 18 and 70 years
• Diagnosis of Substance-Induced Depressive Disorder as per DSM-5 criteria

You may not qualify if:

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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Shiraz University of Medical Sciences, Shiraz, Iran

Shiraz, Fars, 71356-44144, Iran

Location

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: July 15, 2022
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

IR (1)