CTRI/2018/10/016209
Completed
未知
An observational study for schizophrenia relapse prediction
Janssen Research and Development LLC0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Janssen Research and Development LLC
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
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
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
Outcomes
Primary Outcomes
Not specified
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