Actively Recruiting
Neural Mechanisms of Anticholinergic Burden in Mid- to Late-Life Schizophrenia Spectrum
Led by Deepak K. Sarpal, M.D. · Updated on 2026-02-09
105
Participants Needed
1
Research Sites
25 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
Researchers are evaluating whether stopping unnecessary anticholinergic drugs, specifically benztropine or trihexyphenidyl, can improve quality of life, daily functioning, and brain function in people aged 40 to 70 with schizophrenia or schizoaffective disorder. These drugs are often prescribed but may not always be needed, so the study aims to see if reducing their use benefits patients. This is a Phase 4 randomized clinical trial including a healthy control group for comparison. Participants will be divided into three groups: one group will have their unnecessary anticholinergic drugs gradually stopped under routine clinical care, another group will continue their usual anticholinergic medication, and a third group of healthy individuals with minimal anticholinergic use will be observed. The study lasts for six months, during which participants receive evaluations and brain imaging to track changes. During the study, participants will have baseline assessments followed by regular evaluations of cognitive performance, quality of life, daily functioning, brain connectivity, brain activity in cognitive networks, and brain glutamate levels. Magnetic resonance imaging (MRI) will be used to monitor brain changes. The research team will closely observe these measures over six months to understand the effects of reducing anticholinergic drug use.
CONDITIONS
Brief Title
Anticholinergic Deprescription in Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 70 years
- Primary diagnosis of schizophrenia or schizoaffective disorder confirmed by clinical interview
- Prescribed benztropine or trihexyphenidyl for at least 6 months
- Anticholinergic Cognitive Burden Scale (ACBS) score of 3 or higher
- Mild or no extrapyramidal symptoms as assessed by clinical pharmacists and prescribers
- Able and willing to provide informed consent
- Healthy controls aged 40 to 70 years who can provide informed consent
You will not qualify if you...
- Serious side effects from anticholinergic drugs requiring immediate removal
- Serious neurological or medical conditions affecting the brain, such as Parkinson's disease, dementia, multiple sclerosis, lupus, or traumatic brain injury
- High risk of suicidal or homicidal behavior
- Cognitive or language issues preventing informed consent
- Contraindications to MRI, such as having a pacemaker
- Current substance use disorder confirmed by clinical interview
- Concurrent treatment with electroconvulsive therapy
- Healthy controls with history of psychotic illness or active psychiatric disorders
- Healthy controls with ACBS score greater than 1
- Neurological or serious non-psychiatric disorders affecting brain function in healthy controls
- Healthy controls with family history of psychosis
- Use of anticholinergic drugs for reasons other than schizophrenia spectrum disorders in healthy controls
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either deprescription of benztropine or trihexyphenidyl per routine clinical care or continue their current anticholinergic medication without deprescription.
Visits occur as part of routine clinical care with assessments at baseline and 6 months
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.
S
Shaun M. Eack, Ph.D.
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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