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Psych Congress  

Qualitative Clinical Trial Exit Interviews Evaluating Treatment Benefit, Burden, and Satisfaction in Patients With Schizophrenia

Authors  

Adam Simmons, MPH-Alkermes, Inc.; Julia Carpenter-Conlin, MSW-Alkermes, Inc.; Leona Bessonova, PhD-Alkermes, Inc.; Amy O'Sullivan, PhD-Alkermes, Inc.; David McDonnell, MD-Alkermes Pharma Ireland Limited; Cory Saucier, MPH-Optum; Michelle White, PhD-Optum; April Foster, BS-Optum; Jakob Bjorner, MD, PhD-Optum; Olga Lapeyra, MD, CCRP-Segal Trials; David Walling, PhD-CNS Network

Sponsor  
Alkermes, Inc.

Background: An open-label extension study (NCT02873208) evaluated the long-term tolerability, safety, and efficacy of combination olanzapine/samidorphan (OLZ/SAM) treatment in patients with schizophrenia. This qualitative substudy explored perceptions of benefit, burden, and satisfaction with previous medications and OLZ/SAM.

Methods: Semi-structured interviews (≈60 minutes; audio-recorded) were conducted. Interviewer sensitivity training, senior interviewer oversight, and a list of common medications to aid recall supported data collection. Interview transcripts were content coded and analyzed (NVivo v11.0).

Results: All 41 patients reported a lifetime burden with schizophrenia adversely impacting employment, relationships, emotional health, social activities, and daily tasks. Hospitalization for schizophrenia management was another reported aspect of disease burden. Although most (n=32) patients reported previous medication benefits, side effects affecting physical, emotional/behavioral, and cognitive functioning were reported by all (n=41). Following OLZ/SAM treatment, 39/41 patients (95%) reported improvements in symptoms including hallucinations, paranoia, depression, sleep, and concentration. Furthermore, patients described improvements in self-esteem, social activities, relationships, and daily activities. Twenty-three patients (56%) reported side effects attributed to OLZ/SAM; lack of energy (n=12 [29%]) and dry mouth (n=5 [12%]) were most common. Twenty-four (59%) patients were "very satisfied" with OLZ/SAM; most (n=35 [85%]) preferred to continue OLZ/SAM vs switching to another medication. As most substudy patients (n=40; 98%) completed the extension study, satisfied patients may be overrepresented in this analysis.

Conclusion: This qualitative interview approach provided valuable insight into patients' experiences with previous medications and OLZ/SAM. Overall, most patients reported treatment satisfaction and improvements in symptoms, function, and health-related quality of life with OLZ/SAM.

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