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A Study for Schizophrenia Relapse Prediction | Clinical Trials | Clareo Health

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A Study for Schizophrenia Relapse Prediction

An Observational Study for Schizophrenia Relapse Prediction

NCT03629951•Janssen Research & Development, LLC

Summary

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.

Eligibility

Age

18 - 50 years

Sex

ALL

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)

Locations (10)

Panchshil Hospital

Ahmedabad, India

Ratandeep Multispeciality Hospital

Ahmedabad, India

Asha hospital

Hyderabad, India

Mahendru Psychiatric Centre

Kanpur, India

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

Key Dates

Start Date

November 29, 2018

Primary Completion Date

December 31, 2021

Completion Date

December 31, 2021

Last Updated

April 27, 2025

Enrollment

333

ACTUAL participants

Conditions

Schizophrenia

Interventions

Oral Antipsychotics (OAP)

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study for Schizophrenia Relapse Prediction

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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