Health Condition 1: F20-F29- Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders
Conditions
Interventions
None listed
Sponsors
STEP Program supported by the Gustavus and Louise Pfeiffer Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Participants will be approached for recruitment in this study if they have a diagnosis of schizophrenia or schizophreniform disorder based on the DSM-5 guidelines, as diagnosed by two trained psychiatrists and confirmed using the SCID-5-CV. Other selection criteria include a duration of illness of 13 years, any gender, antipsychotic naïve (never prescribed antipsychotics) or antipsychotic free (off antipsychotics for >2 months)
Exclusion criteria
Exclusion criteria: Pregnant or post-partum state, clinically discernible neurological disorders or visual and hearing impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in total BPRS scores, GSDS mean disability rating and composite cognitive performance index from baseline assessments to 1-year follow-up will be the three outcomes of interest examined. Any participant with a clinically insufficient treatment response in the first 1.5 months of treatment would be deemed as a treatment non-responder, defined as 20% improvement on the total BPRS scores at the 1.5 month follow up. If there is 20% improvement at the 1.5 month follow-up, we will re-evaluate them at the three month follow-up for treatment non-response, which would then be defined as persistence of moderate or greater severity (â?¥ 4 on BPRS or â?¥ 3 SANS) of positive and negative symptoms.Timepoint: Baseline, 6 weeks, 3 months, 6 months, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in total BPRS scores, GSDS mean disability rating and composite cognitive performance index from baseline assessments to 6 and 12 month follow-up will be the secondary outcomes of interest examined. Timepoint: 6 months and 12 months from recruitment | — |
Countries
India
Contacts
Public ContactURVAKHSH MEHERWAN MEHTA
National Institute of Mental Health and Neurosciences (NIMHANS)
Outcome results
None listed