A study on adjusting Fluoxetine dose with a beneficial gut bacteria to improve treatment in people with depression

Pharmacometric-guided dose optimisation of Fluoxetine with adjunctive Akkermansia muciniphila in major depressive patients - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108985

Enrollment

Registered

2026-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: F688- Other specified disorders of adultpersonality and behavior

Interventions

Intervention1: SSRI AND PROBIOTIC: FLUOXETINE 20MG once daily every morning after 2 hours of breakfast at least for 12 months according to the NICE guidelines AND PASTEURISED AKKERMANSIA MUCINIPHILA

Eligibility

Inclusion criteria

Inclusion criteria: MAJOR DEPRESSIVE DISORDER PATIENTS DIAGNOSED WITH DSM 5 TR CRITERIA AND WILLING TO INITIATE FLUOXETINE WOMEN WITH A CHILD BEARING AGE WITH NEGATIVE TO PREGNANCY TEST FOLLOWS NICE GUIDELINES NOT CURRENTLY ON ANY PROBIOTICS OTHER ANTIPSYCHOTICS CURRENT MAJOR DEPRESSIVE EPISODE OF MORE THAN OR EQUAL TO 2 WEEKS IN DURATION

Exclusion criteria

Exclusion criteria: PATIENTS WITH PCOD B12 DEFIECIENCY OTHER SEVERE PSYCHIATRIC DISORDERS COMORBID CONDITIONS LIKE INFLAMMATORY BOWEL DISEASE

Design outcomes

Primary

Measure	Time frame
TO IMPROVE THE THERAPEUTIC EFFICACY OF FLUOXETINE IN DEPRESSIVE PATIENTSTimepoint: Baseline Week 4 Week 8 Week 12	—

Secondary

Measure	Time frame
IMPROVEMENT IN SHORT CHAIN FATTY ACIDS CHANGES IN GUT MICROBIOTA COMPOSITIONTimepoint: BASELINE WEEK 12	—

Countries

India

Contacts

Public ContactRAMYA A

JSS COLLEGE OF PHARMACY

kparun@jssuni.edu.in9994934663

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026