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| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODSCH4001 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Schizophrenia | Participants will not receive any intervention as a part of this study. Participants with a diagnosis of schizophrenia or schizoaffective disorder receiving oral antipsychotics (OAP) for example, risperidone (1 to 6 milligram [mg] once daily [OD] to twice a day [BID]), olanzapine (5 to 20 mg OD), haloperidol (5 to 20 mg OD to thrice a day [TID]) etc, per their treating physician/clinician instruction will be observed. The primary data source for this study will be the clinical assessments by the treating physician of each participant conducted as a part of routine clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Antipsychotics (OAP) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with clinical diagnosis of schizophrenia receiving an oral antipsychotic (OAP) treatment regimen directed by their treating clinician will be observed.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panchshil Hospital | Ahmedabad | 380005 | India | |||
| Ratandeep Multispeciality Hospital |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014150 | Antipsychotic Agents |
| ID | Term |
|---|---|
| D014149 | Tranquilizing Agents |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Up to approximately 3 years |
| Ahmedabad |
| 380008 |
| India |
| Asha hospital | Hyderabad | 500034 | India |
| Mahendru Psychiatric Centre | Kanpur | 208005 | India |
| Ahana Hospitals | Madurai | 625020 | India |
| Kasturba Medical College Hospital | Manipal | 576104 | India |
| Meera Hospital | Mumbai | 421301 | India |
| Meditrina Institute of Medical Sciences | Nagpur | 440010 | India |
| GMERS Medical College and Hospital | Vadodara | 390021 | India |
| Deva Institute of Health Care and Research Pvt Ltd | Varanasi | 221005 | India |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D011619 | Psychotropic Drugs |