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

Published online by Cambridge University Press:  10 May 2021

Adam Simmons
Affiliation:
Alkermes, Inc., Waltham, MA, USA
Julia Carpenter-Conlin
Affiliation:
Alkermes, Inc., Waltham, MA, USA
Leona Bessonova
Affiliation:
Alkermes, Inc., Waltham, MA, USA
Amy K. O’Sullivan
Affiliation:
Alkermes, Inc., Waltham, MA, USA
David McDonnell
Affiliation:
Alkermes Pharma Ireland Limited, Dublin, Ireland
Cory Saucier
Affiliation:
Optum, Inc., Johnston, RI, USA
Michelle K. White
Affiliation:
Optum, Inc., Johnston, RI, USA
April M. Foster
Affiliation:
Optum, Inc., Johnston, RI, USA
Jakob B. Bjorner
Affiliation:
Optum, Inc., Johnston, RI, USA
Olga Lapeyra
Affiliation:
Segal Trials, Miami, FL, USA
David P. Walling
Affiliation:
CNS Network, LLC, Garden Grove, CA, USA
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Abstract

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Objective

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 sub study 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.

Funding

Alkermes, Inc.

Type
Abstracts
Copyright
© The Author(s), 2021. Published by Cambridge University Press

Footnotes

Presenting Author: Adam Simmons