Major Depression
Conditions
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)
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. 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_SUPPLEMENTLactobacillus 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.
OTHERPlacebo 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)
Sponsors
Dr Sadia yasir
Allama Iqbal Medical College
Jinnah Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score | Baseline to Week 6 | 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. |
Countries
Pakistan
Contacts
CONTACTSenior Registrar, Psychiatry Department
PRINCIPAL_INVESTIGATORSadia Yasir, MBBS FCPS
Jinnah hospital lahore/ Allama Iqbal Medical college lahore, Pakistan
Outcome results
None listed