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

Effect of Psychobioticsbe (Combined Lactobacillus Helveticus and Bifidobacterium Longus) With Standard Antiddepressants in Treatment of Major Depressive Disorder

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

Study Overview

• Status: Recruiting
• Conditions: Major Depression
• Intervention / Treatment: Dietary supplement: Lactobacillus Helveticus and bifidobacterium Longum; Other: Placebo Capsule(s)

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Senior Registrar, Psychiatry Department; Phone Number: +923314567690; Email: aroojfatima47@yahoo.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54550
      • Recruiting
      • Allama Iqbal Medical College, Jinnah Hospital Lahore
      • Contact: Head Of Department, PSYCHIATRY DEPARTMENT; Phone Number: +923334746639; Email: psychjhl@aimc.edu.pk
      • Sub-Investigator: AROOJ FATIMA, MBBS, MD PSYCHIATRY
      • Sub-Investigator: ZAINAB MAHMOOD, MBBS, FCPS
      • Sub-Investigator: TEHREEM KHAN, MBBS
      • Sub-Investigator: TARIQ ABBAS, MBBS
      • Sub-Investigator: MOHSIN ALI, MBBS
      • Sub-Investigator: TAYYAB RAFIQUE, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interventional Arm; People who are recieving Psychobiotics as an adjunct to the standard treatment.	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 Names: psychobiotics
Placebo Comparator: Placebo Comparator; people who will be given placebo capsules along with standard 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score	The primary outcome is the difference in the mean change in the 17-item Hamilton Depression Rating Scale (HDRS-17) total score from baseline to Week 6 between participants receiving psychobiotics (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) plus standard antidepressant treatment and those receiving placebo plus standard antidepressant treatment. Higher reductions in HDRS-17 scores indicate greater improvement in depressive symptoms.	Baseline to Week 6

Collaborators and Investigators

• Sponsor: Dr Sadia yasir
• Collaborators: Allama Iqbal Medical College

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): January 25, 2027

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Major Depressive Disorder; Adjunctive Therapy; Gut-Brain Axis; Bifidobacterium longum; Psychobiotics; Placebo-Controlled Trial; Lactobacillus Helveticus; Selective Serotonin Reuptake Inhibitors (SSRIs); Hamilton Depression Rating Scale (HDRS-17)
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: ERB 198/06/01-01-2026/AIMC/JHL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No