Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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