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

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Depressive Disorder; Depressive Disorder, Major Depressive Disorder

Treatments: Drug: Placebo; Drug: The probiotic supplement (Moodamin capsuls)

Study type: Interventional

Funder types: Other

Identifiers

NCT06790823

IR.SUMS.REC.1400.442

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

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

Treatment:

Drug: The probiotic supplement (Moodamin capsuls)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo