Status:
COMPLETED
Prediction of Relapse in Schizophrenia/Schizoaffective Disorder With Smartphones and On-body Sensors
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
19-45 years
Brief Summary
This study is dedicated to achieving a better understanding of how to identify patterns that indicate someone might be at high risk for relapse in schizophrenia or schizoaffective disorder. The invest...
Detailed Description
This study will follow a group of participants who have recently been discharged from the emergency room or the hospital using several new "high-tech" methods, including the use of a smartphone, healt...
Eligibility Criteria
Inclusion
- DSM - 5 criteria for schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual (DSM) criteria
- Males and females 19 years or older
- Discharged from the University of Alabama at Birmingham (UAB) inpatient psychiatric unit or the emergency department (ER) or currently seen by UAB outpatient physicians
- Prescribed and maintained on antipsychotic medication
- Psychiatrically stable for a period of at least two weeks
- Willingness and capability to comply with the study procedures, including responding to smartphone application prompts, wearing the optional on-body electronic devices
- Each participant must activate the Ginger.io User License Agreement (ULA) indicating that he or she understands how data security will be maintained on the smartphones.
- Each participant must sign an Informed Consent (ICF) indicating that he or she understands the purpose of the procedures required for the study and are willing to participate in the study
Exclusion
- Physical and or clinical disabilities such as hearing, vision, or motor impairment, which make it impossible to operate a smartphone or respond to prompts (determined using demonstration smartphone for screening)
- Inability to understand the consent process as determined by the Evaluation to Give Consent
- Substance Use Disorder rating of severe (6 or more symptoms) according to the DSM-5
- Participants with any known skin allergy to the use of adhesives and/or lithium will be excluded from the optional Metria patch segment of the study
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02224430
Start Date
August 1 2014
End Date
December 31 2019
Last Update
July 28 2021
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294