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Anticholinergic Deprescription in Schizophrenia | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Anticholinergic Deprescription in Schizophrenia

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

NCT06562608•Deepak K. Sarpal, M.D.

Summary

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

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Primary DSM-defined diagnosis of schizophrenia or schizoaffective disorder verified by the Structured Clinical Interview for DSM-5 (SCID).
•2. Prescription of benztropine or trihexyphenidyl for at least 6 months
•3. Age 40-70 years.
•4. ACBS score \>= 3.
•5. Mild or absent extrapyramidal symptoms (Determined by clinical pharmacists and prescribers).
•6. Competency and willingness to sign informed consent.
•1. Age 40-70 years.
•2. Competency and willingness to sign informed consent.

Exclusion Criteria

•1. Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics,
•2. 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).
•3. Significant risk of suicidal or homicidal behavior.
•4. Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.
•5. Contraindications for MR imaging (e.g., a pacemaker).
•6. 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.
•7. Patients concurrently treated with electroconvulsive therapy will be excluded because of its effects on cognition.
•1. No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP.
•2. Score greater than 1 on the ACB scale.
•3. MR imaging contraindications.
+3 more criteria

Locations (1)

UPMC Western Psychiatric Hospital/University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

February 1, 2025

Primary Completion Date

December 31, 2028

Completion Date

June 30, 2029

Last Updated

February 9, 2026

Enrollment

105

ESTIMATED participants

Conditions

SchizophreniaSchizoaffective Disorder

Interventions

Anticholinergic Deprescription

DRUG

No Anticholinergic Deprescription

DRUG

Contacts

Deepak K Sarpal, M.D.

CONTACT

4122465618 sarpaldk@upmc.edu

Shaun M. Eack, Ph.D.

CONTACT

412.648.9029 sme12@pitt.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Anticholinergic Deprescription in Schizophrenia

Inclusion Criteria

Exclusion Criteria

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