Anticholinergic Deprescription in Schizophrenia

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Deepak K. Sarpal, M.D.
Study ID
NCT06562608
Phase
PHASE4
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Feb 1, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in cognitive performance [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Western Psychiatric Hospital/University of PittsburghPittsburghPennsylvania15213
Tori Blazinski
Deepak K. Sarpal, M.D. (PRINCIPAL_INVESTIGATOR)
Shaun M. Eack, Ph.D. (PRINCIPAL_INVESTIGATOR)

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