A Study for Schizophrenia Relapse Predictio
- Conditions
- Health Condition 1: F20- Schizophrenia
- Registration Number
- CTRI/2018/10/016209
- Lead Sponsor
- Janssen Research and Development LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
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 & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method