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

NCT07691749 | Recruiting

• 1 other identifier: ERB 198/06/01-01-2026/AIMC/JHL
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does adding psychobiotics lower depression symptoms more than a placebo (a look-alike capsule with no active ingredients)?
2. 2.Is it safe and well tolerated when taken with standard antidepressant treatment?
3. 3.Continue taking their prescribed antidepressant medicine. Be randomly assigned to receive either a psychobiotic capsule or a placebo capsule once daily for 6 weeks.
4. 4.Complete depression assessments at the start of the study and again at 3 and 6 weeks.
5. 5.Attend regular follow-up visits so researchers can monitor symptoms, side effects, and overall progress

Conditions

Major Depression

Keywords

Psychobiotics; Major Depressive Disorder; Lactobacillus Helveticus; Bifidobacterium longum; Gut-Brain Axis; Selective Serotonin Reuptake Inhibitors (SSRIs); Adjunctive Therapy; Placebo-Controlled Trial; Hamilton Depression Rating Scale (HDRS-17)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Interventional Arm

ACTIVE COMPARATOR

People who are recieving Psychobiotics as an adjunct to the standard treatment.

Dietary Supplement: Lactobacillus Helveticus and bifidobacterium Longum

Placebo Comparator

PLACEBO COMPARATOR

people who will be given placebo capsules along with standard treatment

Other: Placebo Capsule(s)

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.

Also known as: psychobiotics

Interventional Arm

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)

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Sadia yasir: lead
• Allama Iqbal Medical College: collaborator
• Jinnah Hospital: collaborator

Study Sites (1)

Allama Iqbal Medical College, Jinnah Hospital Lahore

Lahore, Punjab Province, 54550, Pakistan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sadia Yasir, MBBS FCPS

  Jinnah hospital lahore/ Allama Iqbal Medical college lahore, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Senior Registrar, Psychiatry Department

CONTACT

+923314567690; aroojfatima47@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor/ Head of Department

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)