A Study for Schizophrenia Relapse Prediction

An Observational 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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Oral Antipsychotics (OAP)

• Study Type: Observational
• Enrollment (Actual): 333

Contacts and Locations

Study Locations

• India
  • Ahmedabad, India, 380008
    • Ratandeep Multispeciality Hospital
  • Ahmedabad, India, 380005
    • Panchshil hospital
  • Hyderabad, India, 500034
    • Asha hospital
  • Kanpur, India, 208005
    • Mahendru Psychiatric Centre
  • Madurai, India, 625020
    • Ahana Hospitals
  • Manipal, India, 576104
    • Kasturba Medical College Hospital
  • Mumbai, India, 421301
    • Meera Hospital
  • Nagpur, India, 440010
    • Meditrina Institute of Medical Sciences
  • Vadodara, India, 390021
    • GMERS Medical College and Hospital
  • Varanasi, India, 221005
    • Deva Institute of Health Care and Research Pvt Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with clinical diagnosis of schizophrenia receiving an oral antipsychotic (OAP) treatment regimen directed by their treating clinician will be observed.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: Oral Antipsychotics (OAP); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antipsychotic Agents
• Other Study ID Numbers: CR108481; NOPRODSCH4001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No