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A Prospective Observational Study Examining the Real-World Clinical and Treatment Outcomes of Parkinson’s Disease Psychosis in the United States
- Jennifer G. Goldman, Jeffrey P. Trotter, Niccole Larsen, Dilesh Doshi, Nazia Rashid
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- Journal:
- CNS Spectrums / Volume 28 / Issue 2 / April 2023
- Published online by Cambridge University Press:
- 14 April 2023, pp. 252-253
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Introduction
Psychosis is a common feature of Parkinson’s Disease (PD), affecting approximately 50% of PD patients during their disease course. The INSYTE study was the first prospective, real-world, observational study examining the outcomes of both treated and untreated patients with PD Psychosis (PDP).
MethodsPDP patients were enrolled from 76 US academic centers and community sites from 03/21/2017 to 03/08/2021. Patients were included in the final analytical cohort if they had a baseline visit and at least 1 follow-up visit within 3 years; due to the variability of follow-up for each patient within the 3-year period, all study outcomes were assessed in patients with at least one baseline and two follow-up visits within 1 year. No specific visit schedule was imposed; all interactions were established by the investigators. Questionnaires were completed at follow-up visits and assessments focused on PDP treatment utilization, treatment patterns, clinical outcomes, caregiver burden, quality of life, and resource utilization.
Results760 patients were initially enrolled; 635 patients (84%) were included in the final study group, and 441 patients (69%) were included in the analysis. 281 patients (64%) had no antipsychotic treatment at enrollment (untreated group) vs 160 (36%) who had received an antipsychotic at enrollment (treated group). At enrollment, patients in the untreated vs treated group, respectively, had a mean PD duration of 8.05 vs 10.23 years, mean duration of PDP features of 2.20 vs 3.10 yrs, and had a PDP diagnosis for a mean of 1.42 vs 2.16 yrs. Most patients in the untreated group (n=221, 77%) received no antipsychotics through follow-up. The groups were balanced in terms of age (mean 73.9 vs 73.4 yrs) and sex (65.1% vs 63.1% male). The untreated group had higher rates of hypertension (44.5% vs 36.8%) and diabetes (12.8% vs 8.8%); however, the treated group had higher rates of depression (25.6% vs 41.3%) and anxiety (22.8% vs 26.9%). The percent change from baseline at 12 months in total psychosis, hallucination, and delusion scores for the untreated group showed greater worsening than the treated group: 32.3% vs 29.3%; 29.3 % vs 25.0%; and 29.3 % vs 25.0%, respectively, as did daytime sleepiness scores (51.6% vs 40.8%). Measures of PD severity (non-motor and motor MDS-UPDRS scores) and health-related quality of life showed less worsening for the untreated group vs treated group at 12 months. Caregiver burden (per the ZBI) was lower in the untreated group vs the treated group (81.5% vs 90.0%).
ConclusionsIn this descriptive analysis, untreated patients had shorter duration of PD, fewer PDP symptoms at baseline, and lower rates of mental health comorbidities vs treated patients. The untreated PDP patients had greater worsening in their psychosis and sleepiness scores at 12 months versus the treated group, yet remained untreated. Future studies are needed to better understand clinicians’ rationale for withholding PDP treatment.
FundingAcadia Pharmaceuticals, Inc
Clinical Management of Patients with Schizophrenia Treated with Long-Acting Injectable Antipsychotics and Telepsychiatry Use During COVID-19 Pandemic
- Leona Bessonova, Elizabeth Keane, Eric Achtyes, Philip D. Harvey, John M. Kane, Stephen R. Saklad, Jeffrey Trotter, Amy Claxton, Tiffany Hatfield, James McGrory, Wahidullah Noori, Amy K. O’Sullivan, Joshua E. Biber, Asia Sikora Kessler, Aaron Yarlas, Dawn I. Velligan
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- Journal:
- CNS Spectrums / Volume 27 / Issue 2 / April 2022
- Published online by Cambridge University Press:
- 28 April 2022, p. 230
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Background
The COVID-19 pandemic substantially impacted care of patients with schizophrenia treated with long-acting injectable antipsychotics (LAIs). This study examined how clinics adapted operations to maintain a standard of care for these patients after pandemic onset.
MethodsOnline surveys were completed in October-November 2020 by one principal investigator (PI) or PI-appointed designee at 35 clinics participating in OASIS (NCT03919994). Items concerned pandemic impacts on clinic operations, particularly telepsychiatry, and on the care of patients with schizophrenia treated with LAIs.
ResultsAll 35 clinics reported using telepsychiatry; 20 (57%) implemented telepsychiatry after pandemic onset. Telepsychiatry visits increased from 12%-15% to 45%-69% across outpatient visit types after pandemic onset; frequency of no-show and/or canceled telepsychiatry visits decreased by approximately one-third. Nearly half of clinics increased the frequency of telepsychiatry visits for patients with schizophrenia treated with LAIs. Approximately one-third of participants each reported switching patients treated with LAIs to longer injection interval LAIs or to oral antipsychotics. The most common system/clinic- and patient-related barrier for telepsychiatry visits was lower reimbursement rate and access to technology/reliable internet, respectively. Almost all participants (94%) were satisfied with telepsychiatry for maintaining care of patients with schizophrenia treated with LAIs; most predicted a hybrid of telepsychiatry and office visits post-pandemic.
ConclusionsChanges made by clinics after pandemic onset were viewed by almost all participants as satisfactory for maintaining a standard of care for patients with schizophrenia treated with LAIs. Most participants predicted continuing telepsychiatry to support patient care post-pandemic; equitable access to telepsychiatry will be important in this regard.
FundingAlkermes, Inc.