A Study for Schizophrenia Relapse Prediction

Schizophrenia Clinical Trial

Official title:

An Observational Study for Schizophrenia Relapse Prediction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629951
• Other study ID #: CR108481
• Secondary ID: NOPRODSCH4001
• Status: Completed
• Start date: November 29, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
India	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

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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