Psychobiotics added to antidepressants in major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial compares adjunctive psychobiotic capsules to placebo in adults with major depressive disorder who are on stable antidepressant therapy. Participants take the study capsules daily for 6 weeks while continuing their usual antidepressant treatment. Depression severity is measured at baseline, week 3, and week 6, with safety, tolerability, and adherence monitored throughout. The study aims to see if psychobiotics provide greater symptom relief and to characterize safety in combination with standard antidepressants.

Why it matters

Who can join: the full rules

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

Where it's running

• Allama Iqbal Medical College, Jinnah Hospital Lahore
  Lahore, Punjab Province, Pakistan Recruiting

Study contacts

• Principal investigator: Arooj Fatima — Jinnah Hospital
• Study coordinator: Arooj Fatima Senior Registrar, Psychiatry Department, MBBS, MD Psychiatry
• Email: aroojfatima47@yahoo.com
• Phone: +923314567690

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.