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

Sponsor: Dr Sadia yasir • ClinicalTrials.gov ID: NCT07691749

Registry updated: 2026-09-30

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Description

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

Interventions

Lactobacillus Helveticus and bifidobacterium Longum (Dietary supplement)
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.
Placebo Capsule(s) (Other)
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)

Eligibility criteria

Inclusion Criteria: 1. Patients diagnosed with major depressive disorder (According to Diagnostic \& Statistical Manual-5 criteria (as per operational definition) 2. Age 18 to 60 years 3. Both genders 4. Patients who are able to speak and understand Urdu/ English language. 5. Patients who are on stable doses of oral selective serotonin reuptake inhibitors for at least two weeks prior to enrollment in the study 6. Patients with cut off score of \> 24 as assessed by 17 item clinician administered Hamilton depression rating scale. Exclusion Criteria: * Severe psychiatric comorbidities (schizophrenia, bipolar disorder, co morbid substance use) * Individuals with weakened immune systems: This includes patients undergoing chemotherapy, transplant recipients, and people with conditions like HIV/AIDS. * Individuals on chronic medication: People on chronic pharmacological therapy, especially with anti-inflammatory drugs or who have recently used antibiotics in last 2 weeks. * Pregnant or lactating women * Current use of probiotics or prebiotics

Conditions

Major Depression

Locations

Allama Iqbal Medical College, Jinnah Hospital Lahore — Lahore, Punjab Province, Pakistan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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