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Clinical Trials/CTRI/2018/10/016209
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Observational

Investigators

Sponsor
Janssen Research and Development LLC

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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