The purpose of this study is to identify if there are self-reported/caregiver reported or objective measures that can predict near-term relapse (within 1 month or at another identified time point before meeting the criteria for relapse) or early symptomatic changes indicative of pre-relapse.
Study Type
OBSERVATIONAL
Enrollment
333
This is an observational study. Participants enrolled in this study will continue to receive routine treatment of OAPs for example, risperidone (1 to 6 mg OD to BID), olanzapine (5 to 20 mg OD), haloperidol (5 to 20 mg OD to TID) etc, as directed by their treating physician.
Panchshil Hospital
Ahmedabad, India
Ratandeep Multispeciality Hospital
Ahmedabad, India
Asha hospital
Hyderabad, India
Mahendru Psychiatric Centre
Kanpur, India
Number of Participants with Relapse
Relapse is defined as achieving any of the following: clinically meaningful worsening of symptoms as determined by the treating physician's judgment; involuntary or voluntary admission to a psychiatric hospital for decompensation of the participant's schizophrenic symptoms (psychiatric hospitalization); deliberate self-injury and/or violent behavior resulting in clinically significant injury to the participant or another person or property damage; suicidal or homicidal ideation and aggressive behavior considered as clinically significant (in frequency and severity) in the treating physician's judgment; an increase of at least 2 points from the lowest reported Clinical Global Impression-Severity (CGI-S) score (ranging from 1 \[not ill\] to 7 \[extremely severe\]) captured either at baseline or post baseline. Number of participants with relapse will be determined.
Time frame: Up to Approximately 3 years
Number of Participants in each Clinical State of Schizophrenia
Number of participants in each clinical state (Acute, Stable, and Remission) of schizophrenia will be assessed. The clinical states are defined as: 'Acute' - Clinical Global Impression-Severity (CGI-S) score (ranging from 1 \[not ill\] to 7 \[extremely severe\]) greater than or equal to (\>=)5 anytime during the study; 'Stable' (Tier I) - control of acute symptoms, defined as having a CGI-S score of less than or equal to (\<=)3 for a minimum of 3 months and/or (Tier II) - stable dosage of oral antipsychotic (OAPs) for a minimum of 3 months and control of acute symptoms, defined as having a CGI-S score of \<=4 for a minimum of 3 months; and 'Remission' - a continuous CGI-S scale score of \<=2 for 6 months.
Time frame: Up to approximately 3 years
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Ahana Hospitals
Madurai, India
Kasturba Medical College Hospital
Manipal, India
Meera Hospital
Mumbai, India
Meditrina Institute of Medical Sciences
Nagpur, India
GMERS Medical College and Hospital
Vadodara, India
Deva Institute of Health Care and Research Pvt Ltd
Varanasi, India