Status:
COMPLETED
CAE for Poorly Adherent Individuals With Schizophrenia
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).
Detailed Description
Patients with schizophrenia will be randomly assigned to receive either CAE-S or eTAU following the baseline assessment. The primary feasibility outcomes will be attendance and patient satisfaction (A...
Eligibility Criteria
Inclusion
- Individuals age 18 and older with schizophrenia as confirmed by the Mini International Psychiatric Inventory (MINI)
- Prescribed an antipsychotic medication for treatment of schizophrenia
- Known to have medication treatment adherence problems as identified by the Tablets Routine Questionnaire (TRQ, 20% or more missed medications in past week or past month)
- Ability to be rated on psychiatric rating scales
- Currently in treatment or scheduled to receive treatment at a Community Mental Health Clinic (CMHC) or other clinical setting able to provide mental health care during and after study participation
- Able to provide written, informed consent to study participation
- Has access to electronic device and internet to complete sessions conducted on videoconferencing platform
Exclusion
- Prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence)
- Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
- Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist
- Immediate risk of harm to self or others
- Female who is currently pregnant or breastfeeding
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06061952
Start Date
January 16 2024
End Date
August 9 2025
Last Update
November 18 2025
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106