A Study for Schizophrenia Relapse Prediction

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Schizophrenia

Treatments: Drug: Oral Antipsychotics (OAP)

Study type: Observational

Funder types: Industry

Identifiers

NCT03629951

NOPRODSCH4001 (Other Identifier)

CR108481

Details and patient eligibility

About

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.

Enrollment: 333 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants and their legally acceptable representative where applicable must be able to sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate for the duration of the study
• Have a clinical diagnosis of schizophrenia made by a clinician with understanding of the criteria for schizophrenia or schizoaffective disorder, per the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5), and had at least 1 relapse, in the opinion of the investigator, within the last 12 months prior to date of informed consent
• Must be receiving an OAP treatment regimen at the time of enrollment
• Must be able to speak, read, and understand English and/or the local Indian language as the patient reported outcome instruments will be validated in regional languages
• Caregivers/Informants should be able to sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate for the duration of the study

Exclusion criteria

• Has treatment resistant schizophrenia (that is, currently receiving clozapine or electroconvulsive therapy [ECT])
• Is on long-acting injectable antipsychotic regimen at the time of screening
• Has a moderate to severe substance use disorder (other than nicotine), as determined by the investigator
• Has a significant risk of suicide or active suicidality with a plan as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment
• Has an immediate need for hospitalization (that is, the participant is already in a relapse)

Trial design

333 participants in 1 patient group

Participants with Schizophrenia

Description:

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.

Treatment:

Drug: Oral Antipsychotics (OAP)