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Effectiveness of Gut Bacteria on Depressive Disorder when used along with Tablet Escitalopram.

Effectiveness of Gut Microbiome as an add on to T.ESCITALOPRAM ( Anti Depressant ) in Depressive Disorder: A Randomised Double Blinded Prospective Treatment Evaluation Study - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069746
Enrollment
100
Registered
2024-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features

Interventions

Intervention1: T.ESCITALOPRAM AND C.GUTBRAX: T.ESCITALOPRAM Dose 10mg Frequency one tablet daily in the morning Route of administration is per oral Total duration is 10 weeks C.GUTBRAX Dose 23 Billi

Sponsors

SVS Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

India

Contacts

Public ContactDr K ASHOK REDDY

SVS Medical College and Hospital

kashokreddy60@gmail.com9391041531

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026