NCT07691749Recruiting
Effect of Psychobiotics With Standard Antiddepressants in Treatment of Major Depressive Disorder
Effect of Psychobiotics (Combined Lactobacillus Helveticus and Bifidobacterium Longus) With Standard Antidepressants in Treatment of Major Depressive Disorder.
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 2 Jul 2026
- Start date
- 31 Jan 2026
- Primary completion date
- 25 Dec 2026
- Lead sponsor
- Dr Sadia yasir
- Diseases
- Depression
- NCT number
- NCT07691749
What you commit to
- Study type: Interventional
- Planned participants: 86
- From 31 Jan 2026 to the primary completion date, 25 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Allama Iqbal Medical College, Jinnah Hospital Lahore Coordinator of this site? Confirm its status | Lahore | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.