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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 70
Healthy Volunteers: t
View:

• Primary DSM-defined diagnosis of schizophrenia or schizoaffective disorder verified by the Structured Clinical Interview for DSM-5 (SCID).

• Prescription of benztropine or trihexyphenidyl for at least 6 months

• Age 40-70 years.

• ACBS score \>= 3.

• Mild or absent extrapyramidal symptoms (Determined by clinical pharmacists and prescribers).

• Competency and willingness to sign informed consent.

• Age 40-70 years.

• Competency and willingness to sign informed consent.

Locations
United States
Pennsylvania
UPMC Western Psychiatric Hospital/University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Deepak K Sarpal, M.D.
sarpaldk@upmc.edu
4122465618
Backup
Shaun M. Eack, Ph.D.
sme12@pitt.edu
412.648.9029
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 105
Treatments
Experimental: Anticholinergic Deprescription
In this arm, clinically determined unneeded benztropine or trihexyphenidyl will be deprescribed, per routine care by clinical providers.
Active_comparator: No Anticholinergic Deprescription
In this arm, no deprescription of benztropine or trihexyphenidyl will occur.
No_intervention: Healthy Controls
In this arm, a healthy control group with minimal anticholinergic burden will be examined longitudinally.
Related Therapeutic Areas
Sponsors
Leads: Deepak K. Sarpal, M.D.
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov

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