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

Official title

Effect of Psychobiotics (Combined Lactobacillus Helveticus and Bifidobacterium Longus) With Standard Antidepressants in Treatment of Major Depressive Disorder.

Overview

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

Detailed description

Major depressive disorder (MDD) is a leading cause of disability worldwide, and many patients experience only partial improvement with antidepressant treatment alone. Increasing evidence suggests that the gut-brain axis plays an important role in the pathophysiology of depression. Psychobiotics, including Lactobacillus helveticus and Bifidobacterium longum, may improve depressive symptoms by modulating the gut microbiota, reducing inflammation, and influencing neurochemical pathways.

This study is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of adjunctive psychobiotic therapy in adults with MDD receiving standard antidepressant treatment. Participants will continue their prescribed antidepressant medication and will be randomly assigned to receive either a psychobiotic capsule containing Lactobacillus helveticus and Bifidobacterium longum or a matching placebo once daily for 6 weeks.

Depression severity will be assessed at baseline, Week 3, and Week 6 using validated rating scales. Safety and tolerability will be evaluated through adverse event monitoring, treatment adherence, and regular follow-up visits.

The primary objective is to determine whether adjunctive psychobiotic therapy produces a greater reduction in depressive symptoms compared with placebo. Secondary objectives include evaluating safety, tolerability, treatment adherence, patient satisfaction, and quality of life. The findings will provide evidence on whether psychobiotics are an effective and safe adjunct to antidepressant therapy in adults with major depressive disorder.

Interventions

• 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.
• 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)

Primary outcome measures

• Change in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score [Time frame: Baseline to Week 6]

Eligibility criteria

Inclusion criteria

• Patients diagnosed with major depressive disorder (According to Diagnostic \& Statistical Manual-5 criteria (as per operational definition)
• Age 18 to 60 years
• Both genders
• Patients who are able to speak and understand Urdu/ English language.
• Patients who are on stable doses of oral selective serotonin reuptake inhibitors for at least two weeks prior to enrollment in the study
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Allama Iqbal Medical College, Jinnah Hospital Lahore — Lahore

Identifiers

NCT: NCT07691749 · ERB 198/06/01-01-2026/AIMC/JHL

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗