Clinical trial NCT03629951: A Study for Schizophrenia Relapse Prediction
Official title: An Observational Study for Schizophrenia Relapse Prediction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 criteria: 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)

Primary outcomes:
measure: Number of Participants with Relapse
timeFrame: Up to Approximately 3 years
Secondary outcomes:
measure: Number of Participants in each Clinical State of Schizophrenia
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Panchshil Hospital
city: Ahmedabad
country: India
facility: Ratandeep Multispeciality Hospital
city: Hyderabad
country: India
facility: Asha hospital
city: Kanpur
country: India
facility: Mahendru Psychiatric Centre
city: Madurai
country: India
facility: Ahana Hospitals
city: Manipal
country: India
facility: Kasturba Medical College Hospital
city: Mumbai
country: India
facility: Meera Hospital
city: Nagpur
country: India
facility: Meditrina Institute of Medical Sciences
city: Vadodara
country: India
facility: GMERS Medical College and Hospital
city: Varanasi
country: India
facility: Deva Institute of Health Care and Research Pvt Ltd
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: