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Robust Learning Approaches for Assessing Effects and Effect Heterogeneity of Real World Antipsychotic Treatment Regimes in Elderly Persons with Schizophrenia

Award Number: R01MH130213
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/01/2022
PERIOD OF PERFORMANCE END DATE: 10/31/2027

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Robust Learning Approaches for Assessing Effects and Effect Heterogeneity of Real World Antipsychotic Treatment Regimes in Elderly Persons with Schizophrenia - Project Summary Availability of large longitudinal datasets describing elderly populations with schizophrenia treated in usual care settings present opportunities to expand the limited evidence on outcomes of antipsychotic drug treatment for this population and to learn what works in the real world: which drugs, in what sequence, combination, or intensity, for whom (what racial/ethnic groups, in what social circumstances), and at what risk. While this objective is not new, advances in machine learning and causal inference could improve inferences, and thus generate evidence to answer these questions. Leveraging data generated in usual care settings, we will (a) translate novel statistical methods to assure distributional balance on observed confounders using high- dimensional longitudinal data with multiple competing antipsychotic drugs (multi-valued treatments) and longitudinal treatment patterns (treatment regimens); (b) utilize robust non-parametric or semi-parametric methods; and (c) extend tree-based approaches to simultaneously model effectiveness and safety outcomes to fill evidence gaps. We will link racially/ethnically diverse cohorts of elderly publicly-insured adults with schizophrenia utilizing antipsychotics to geographical indicators of social contextual factors– upstream social determinants of health (SDH) such as household income and crime rates— that are known to influence treatment adherence and other health behaviors. Aim 1 applies causal effect estimation of the index antipsychotic drug prescribed using weighted semi-parametric or non-parametric methods that (a) depend on high-dimensional confounders and (b) may be moderated by patient race/ethnicity and area-level SDH. Aim 2 identifies and characterizes frequently observed treatment regimens that may differ by race/ethnicity and SDH. Aim 3 estimates effectiveness and safety of the treatment regimens identifed in Aim 2, and determines if race/ethnicity or SDH modify treatment effectiveness. Aim 4 estimates the impact of treatment regimens on each individual effectiveness and safety outcome simultaneously, making use of within-patient outcome dependencies. Our proposal has high


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $823,065 )
2026	2026	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	000	4	12/9/2025	NON-COMPETING CONTINUATION	$823,065
														Subtotal = $823,065

Issue Date FY: 2025 ( Subtotal = $714,997 )
2025	2025	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	000	3	11/20/2024	NON-COMPETING CONTINUATION	$714,997
														Subtotal = $714,997

Issue Date FY: 2024 ( Subtotal = $853,759 )
2024	2024	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	000	2	10/18/2023	NON-COMPETING CONTINUATION	$768,382
2024	2024	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	001	2	5/13/2024	NON-COMPETING CONTINUATION	$85,377
														Subtotal = $853,759

Issue Date FY: 2023 ( Subtotal = $866,577 )
2023	2023	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	000	1	11/25/2022	NEW	$866,577
														Subtotal = $866,577

Grand Total All Awards = $3,258,398

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Robust Learning Approaches for Assessing Effects and Effect Heterogeneity of Real World Antipsychotic Treatment Regimes in Elderly Persons with Schizophrenia

Award Number: R01MH130213

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/01/2022

PERIOD OF PERFORMANCE END DATE: 10/31/2027

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