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Effect of Psychobiotics With Standard Antiddepressants in Treatment of Major Depressive Disorder

NCT07691749 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-07-20

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether adding psychobiotics (a combination of Lactobacillus helveticus and Bifidobacterium longum) to standard antidepressant treatment works better than antidepressants alone for adults with major depressive disorder. The study will also learn about the safety of taking these psychobiotics with antidepressants.

The main questions it aims to answer are:

1. Does adding psychobiotics lower depression symptoms more than a placebo (a look-alike capsule with no active ingredients)?
2. Is it safe and well tolerated when taken with standard antidepressant treatment?

Researchers will compare psychobiotic capsules with placebo capsules to see whether psychobiotics improve depression symptoms when used together with standard antidepressants.

Participants will:

1. Continue taking their prescribed antidepressant medicine. Be randomly assigned to receive either a psychobiotic capsule or a placebo capsule once daily for 6 weeks.
2. Complete depression assessments at the start of the study and again at 3 and 6 weeks.
3. Attend regular follow-up visits so researchers can monitor symptoms, side effects, and overall progress

Conditions

Interventions

OTHER

Placebo Capsule(s)

A placebo capsule is an orally administered capsule formulated with inert gelatin and no active ingredients. It has no psychobiotic potential and is pharmacologically inactive. The capsule is not expected to affect study outcomes or interact with oral selective serotonin reuptake inhibitors (SSRIs)

DIETARY_SUPPLEMENT

Lactobacillus Helveticus and bifidobacterium Longum

This study uses a specific combination of two well-studied psychobiotic strains-Lactobacillus helveticus R0052 (1.8 billion CFU) and Bifidobacterium longum R0175 (1.2 billion CFU). These strains have been selected because they may support communication between the gut and the brain and help improve mood when used alongside standard antidepressant treatment.

Sponsors & Collaborators

  • Allama Iqbal Medical College

    collaborator OTHER

  • Jinnah Hospital

    collaborator OTHER

  • Dr Sadia yasir

    lead OTHER

Principal Investigators

  • Sadia Yasir, MBBS FCPS · Jinnah hospital lahore/ Allama Iqbal Medical college lahore, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-12-25
Completion
2027-01-31

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07691749 on ClinicalTrials.gov