A Study for Schizophrenia Relapse Prediction

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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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Panchshil Hospital, Ahmedabad, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

Number of Participants with Relapse

Time frame: Up to Approximately 3 years

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.

Secondary outcomes

Number of Participants in each Clinical State of Schizophrenia

Time frame: Up to approximately 3 years

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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

An Observational Study for Schizophrenia Relapse Prediction

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Aug 14, 2018
Registry last updated: Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed