Actively Recruiting

Phase 4
Age: 40Years - 70Years
All Genders
Healthy Volunteers
NCT06562608

Anticholinergic Deprescription in Schizophrenia

Led by Deepak K. Sarpal, M.D. · Updated on 2026-02-09

105

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

D

Deepak K. Sarpal, M.D.

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Anticholinergic Deprescription in Schizophrenia

Who Can Participate

Age: 40Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary DSM diagnosis of schizophrenia or schizoaffective disorder confirmed by Structured Clinical Interview for DSM-5 (SCID)
  • Prescribed benztropine or trihexyphenidyl for at least 6 months
  • Age between 40 and 70 years
  • Anticholinergic Cognitive Burden Scale (ACBS) score of 3 or higher
  • Mild or no extrapyramidal symptoms as determined by clinical pharmacists and prescribers
  • Competent and willing to provide informed consent
  • For healthy controls: age 40-70 years and competent and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Serious anticholinergic side effects needing immediate removal of anticholinergics (e.g., fever, blurred vision)
  • Serious neurological or medical conditions affecting the brain such as Parkinson's, dementia, multiple sclerosis, lupus, or traumatic brain injury
  • Significant risk of suicidal or homicidal behavior
  • Cognitive, language, or other limitations preventing informed consent
  • Contraindications to MRI (e.g., pacemaker)
  • Current substance use disorder confirmed by SCID; history of substance use disorder in remission allowed
  • Concurrent treatment with electroconvulsive therapy
  • For healthy controls: history of psychotic illness or active Axis I disorder, ACBS score greater than 1, MRI contraindications, neurological or serious non-psychiatric disorders affecting brain function, intellectual disability, family history of psychosis, or current use of anticholinergic medications for other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UPMC Western Psychiatric Hospital/University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

D

Deepak K Sarpal, M.D.

CONTACT

S

Shaun M. Eack, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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