Anticholinergic Deprescription in Schizophrenia

Официальное название

Neural Mechanisms of Anticholinergic Burden in Mid- to Late-Life Schizophrenia Spectrum

Обзор

In this study, the investigators will examine whether a deprescription of unnecessary anticholinergic drugs (benztropine or trihexyphenidyl) can augment quality of life, functioning, and neurocognition in individuals who with schizophrenia. Individuals identified by clinical services who have unneeded prescriptions benztropine or trihexyphenidyl will be eligible for deprescription and study entry. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will will be randomized to either staying on their anticholinergic drugs or undergoing deprescription per routine clinical care, and will undergo follow-up evaluations across 6 months. The investigators predict that reducing and deprescribing these drug, if clinically determined to be unnecessary will will enhance functioning, neurocognition

Вмешательства

• Препарат Anticholinergic Deprescription
  per routine clinical care, people in the active arm of the study will undergo deprescription of benztropine or trihexyphenidyl per routine clinical care.
• Препарат No Anticholinergic Deprescription
  In this arm, no deprescription of benztropine or trihexyphenidyl will occur.

Первичные конечные точки

• Change in cognitive performance [Срок оценки: 6 months]
• Change in scores on quality of life assessments. [Срок оценки: 6 months]
• Change in scores on functional outcome assessments. [Срок оценки: 6 months]
• change in brain functional connectivity. [Срок оценки: 6 months]
• change in activation of neurocognitive networks [Срок оценки: 6 months]
• Brain glutamate concentration [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Primary DSM-defined diagnosis of schizophrenia, schizoaffective disorder, or unspecified psychotic disorder, verified by the Structured Clinical Interview for DSM-5 (SCID).
• Prescription of benztropine or trihexyphenidyl for at least 6 months
• Age 35-70 years.
• ACBS score >= 3.
• Mild or absent extrapyramidal symptoms (Determined by clinical pharmacists and prescribers).
• Competency and willingness to sign informed consent.

Inclusion criteria for the healthy control group:

• Age 40-70 years.
• Competency and willingness to sign informed consent.

Критерии исключения

• Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics,
• Serious neurologic or medical condition/treatment that impacts the brain and Neurodegenerative conditions such as Parkinson's, dementia, etc.; autoimmune conditions such as Multiple Sclerosis (MS) and lupus; as well as traumatic brain injury (TBI).
• Significant risk of suicidal or homicidal behavior.
• Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.
• Contraindications for MR imaging (e.g., a pacemaker).
• Current SCID-verified substance use disorder will be excluded to avoid the confounding impact of significant substance use comorbidity. Participants with a history of substance use disorder that is in early or full remission will be eligible, to enhance generalizability.
• Patients concurrently treated with electroconvulsive therapy will be excluded because of its effects on cognition.

Exclusion criteria for Healthy Control (HC) subjects:

• No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP.
• Score greater than 1 on the ACB scale.
• MR imaging contraindications.
• Neurologic conditions, any serious non-psychiatric disorder that could affect brain functioning, or intellectual disability.
• HC with family history of psychosis will be excluded, as such individuals show subtle, but significant cognitive and neurobiological abnormalities.
• Individuals currently taking anticholinergic medications for reasons other than SSD.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UPMC Western Psychiatric Hospital/University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06562608 · STUDY24050090 · R01MH135096

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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