Depressive Disorder, Depressive Disorder, Major Depressive Disorder
Conditions
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.
Interventions
DRUGThe 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.
DRUGPlacebo
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.
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Beck Depression Severity | 4 weeks | The Beck Depression Severity Questionnaire used to assess the severity of depressive symptoms in participants. |
Countries
Iran
Outcome results
None listed