Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants satisfying the ICD 10-DCR [1993] criteria of schizophrenia 2. Age 18 - 60 years of both sexes. 3. Illness duration of equal to or more than 2 years 4. Patient giving written informed consent. 5. Score between 18 to 25 on screening with Hindi Montreal Cognitive Assessment Test (Hindi MoCA).
Exclusion criteria
Exclusion criteria: 1. Any other major co-morbid psychiatric diagnosis excluding anxiety disorder, dissociative disorder, adjustment disorders and substance dependence excluding nicotine& caffeine. 2. Presence of any medical,surgical and psychiatric emergency. 3. Any current systemic infection or inflammation or autoimmune disorders, currently using antibiotics, glucocorticoids and other probiotics, known hypersensitivity to probiotics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome: Change in cognitive function scores measured by Hindi Montreal Cognitive Assessment (MoCA) from baseline to 4 weeks between probiotic and placebo groups. Timepoint: Time Points: Baseline, 2 weeks, and 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum IL-6, hs-CRP, and BDNF levels. Change in BMI, fasting plasma glucose, and triglyceride levels. Change in PANSS scores. Adverse events (SAFTEE). Timepoint: Time Points: Baseline, 2 weeks, and 4 weeks. | — |
Countries
India
Contacts
CENTRAL INSTITUTE OF PSYCHIATRY ,RANCHI