Health Condition 1: F20-F29- Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders
Conditions
Interventions
Intervention1: Urolithin A: 500mg two capsules per day for 90 days
Control Intervention1: Placebo: Two capsules per day for 90 days
Sponsors
Department of Psychiatry National Institute of Mental Health and Neuro Sciences (NIMHANS)
Eligibility
Inclusion criteria
Inclusion criteria: a.18-50 years both sexes b. A minimum education level of 8th grade c. Schizophrenia and related disorders as per the diagnostic and statistical manual of mental disorders (DSM5) d. On stable antipsychotic dose for minimum 4 weeks with persistent deficit symptoms defined based on MoCA+DSST and/or SANS (defined below) e. Providing written informed consent
Exclusion criteria
Exclusion criteria: a. Patients with prominent psychotic symptoms [Global item of Scale for Assessment of Positive Symptoms >3 59 ]. b. Patients with any co-morbid neurological/medical disorder, or intellectual disability disorder to the severity that impedes the trial participation c. Current psychoactive substance dependence (except caffeine or nicotine) d. Suicidal risk or psychiatric emergency e. Pregnancy/post-partum period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Negative symptoms (Scale for assessment of Negative symptoms) score and Cognitive deficits (Brief Assessment of Cognition in Schizophrenia) composite scoreTimepoint: from baseline to 3 months of the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SANS score and BACS composite scoreTimepoint: from baseline to 1 and 2 months of the intervention;Change in other clinical measures (CAINS, SAPS, BPRS, GAF, GSDS, CGI, MedDRA events and subdomains of BACS)Timepoint: from baseline to 1, 2 and 3 months of the intervention;Urolithin levelsTimepoint: from baseline to 3 months of the intervention;Mitophagy markers, mitochondrial bioenergetics, membrane potentials and Brain MRS markersTimepoint: from baseline to 3 months of the intervention | — |
Countries
India
Contacts
Public ContactShivakumar V
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Outcome results
None listed