Effectiveness of Gut Bacteria on Depressive Disorder when used along with Tablet Escitalopram.
Phase 3
- Conditions
- Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features
- Registration Number
- CTRI/2024/07/069746
- Lead Sponsor
- SVS Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients who have been diagnosed as moderate or severe depressive disorder according to ICD 10 first episode or multiple episodes.
2.Subjects willing to give consent.
Exclusion Criteria
1.Patients diagnosed with Mild Depressive Disorder.
2.Patients diagnosed with Bipolar Depression.
3.Patients with a Pre-existing mental illness other than Depressive disorder.
4.Patients who are diagnosed with Thyroid abnormalities.
5.Patients who were diagnosed with Gastrointestinal infections or with inflammatory bowel disease during 4 weeks before inclusion into the study.
6.Patients who have been on Steroids or Antibiotics during 4 weeks before inclusion into the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in the Hamilton depression rating score (HAM -D 21) is taken as response to the cap.GUTBRAX.Timepoint: Hamilton depression rating score assessment is done on day of recruitment into study then after 2 weeks ,6 weeks and 10 weeks.
- Secondary Outcome Measures
Name Time Method Assess the tolerability of the C.GUTBRAX.Timepoint: Assessing the tolerabilty after 2 weeks of initiation of treatment then after 6 weeks and 10 weeks.