Effect of Psychobiotics With Standard Antiddepressants in Treatment of Major Depressive Disorder
ConditionMajor Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDr Sadia yasir
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lactobacillus Helveticus and bifidobacterium Longum
Dietary supplementThis 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.
Placebo Capsule(s)
Other interventionA 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)
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Interventional ArmActive comparator 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to Week 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr Sadia yasir
Lead sponsor
Jinnah Hospital
Sponsor institution
Allama Iqbal Medical College
Collaborator
Jinnah Hospital
Collaborator
Source ClinicalTrials.gov