Anticholinergic Deprescription in Schizophrenia (NCT06562608) | Clinical Trial Compass
RecruitingPhase 4
Anticholinergic Deprescription in Schizophrenia
United States105 participantsStarted 2025-02-01
Plain-language 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
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Primary DSM-defined diagnosis of schizophrenia, schizoaffective disorder, or unspecified psychotic disorder, verified by the Structured Clinical Interview for DSM-5 (SCID).
. Prescription of benztropine or trihexyphenidyl for at least 6 months
. Age 35-70 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in cognitive performance
Timeframe: 6 months
2
Change in scores on quality of life assessments.
Timeframe: 6 months
3
Change in scores on functional outcome assessments.
. Competency and willingness to sign informed consent.
Exclusion criteria
. Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics,
. Serious neurologic or medical condition/treatment that impacts the brain and Neurodegenerative conditions such as Parkinson's, dementia, etc.; autoimmune conditions such as Multiple Sclerosis (MS) and lupus; as well as traumatic brain injury (TBI).
. Significant risk of suicidal or homicidal behavior.
. Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.
. Contraindications for MR imaging (e.g., a pacemaker).
. Current SCID-verified substance use disorder will be excluded to avoid the confounding impact of significant substance use comorbidity. Participants with a history of substance use disorder that is in early or full remission will be eligible, to enhance generalizability.
. Patients concurrently treated with electroconvulsive therapy will be excluded because of its effects on cognition.
. No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP.