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

NCT ID: NCT06790823

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2023-04-12

Brief Summary

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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

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Conditions

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Depressive Disorder Depressive Disorder, Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

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

Group Type ACTIVE_COMPARATOR

The probiotic supplement (Moodamin capsuls)

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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The probiotic supplement (Moodamin capsuls)

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant or lactating
* Patients who for any reason cannot comply with adequate follow-up
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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seyed hamdollah mosavat

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shiraz University of Medical Sciences, Shiraz, Iran

Shiraz, Fars, Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.SUMS.REC.1400.442

Identifier Type: -

Identifier Source: org_study_id

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