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| Name | Class |
|---|---|
| Allama Iqbal Medical College | OTHER |
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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:
Researchers will compare psychobiotic capsules with placebo capsules to see whether psychobiotics improve depression symptoms when used together with standard antidepressants.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Arm | Active Comparator | People who are recieving Psychobiotics as an adjunct to the standard treatment. |
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| Placebo Comparator | Placebo Comparator | people who will be given placebo capsules along with standard treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus Helveticus and bifidobacterium Longum | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
Severe psychiatric comorbidities (schizophrenia, bipolar disorder, co morbid substance use)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Senior Registrar, Psychiatry Department | Contact | +923314567690 | aroojfatima47@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allama Iqbal Medical College, Jinnah Hospital Lahore | Recruiting | Lahore | Punjab Province | 54550 | Pakistan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 1, 2026 | Jul 2, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Placebo Capsule(s) | Other | 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) |
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