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
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
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
Outcome results
None listed