Anticholinergic Deprescription in Schizophrenia
Neural Mechanisms of Anticholinergic Burden in Mid- to Late-Life Schizophrenia Spectrum
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether stopping unneeded benztropine or trihexyphenidyl can improve daily life, thinking, and memory in people with schizophrenia or related disorders. Participants will be assigned by chance to keep taking the drug or stop it through their usual care, with follow-up visits over 6 months. The study also includes a healthy comparison group.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- For the main study: Be 35–70 years old.
- Have schizophrenia, schizoaffective disorder, or an unspecified psychotic disorder, confirmed through a study interview.
- Have taken prescribed benztropine or trihexyphenidyl for at least 6 months, with the care team finding it is no longer needed.
- Have an ACBS score of at least 3, a measure of the effects of anticholinergic medicines.
- Have mild or no drug-related movement problems, as judged by the care team.
- Be able and willing to understand the study and sign a consent form.
- For the healthy comparison group: Be 40–70 years old and able and willing to understand the study and sign a consent form.
Who can't join
- Main study: Serious side effects, such as fever or blurred vision, that require stopping the drug right away.
- Main study: A serious illness or treatment that affects the brain, including Parkinson’s disease, dementia, multiple sclerosis, lupus, or a brain injury.
- Main study: A high risk of harming yourself or others, or thinking, language, or other problems that prevent informed consent.
- Main study: A reason you cannot safely have an MRI scan, such as a pacemaker, or current electroconvulsive therapy (ECT).
- Main study: A current substance use disorder confirmed by interview. A past disorder that is in early or full remission is allowed.
- Healthy comparison group: A personal or family history of psychosis, or a current mental health disorder covered by the study’s screening interview.
- Healthy comparison group: An ACB medicine-effects score above 1, or current use of anticholinergic medicines for reasons other than schizophrenia-related disorders.
- Healthy comparison group: A reason you cannot safely have an MRI, a nerve or brain condition, a serious physical illness that could affect the brain, or an intellectual disability.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Primary DSM-defined diagnosis of schizophrenia, schizoaffective disorder, or unspecified psychotic disorder, verified by the Structured Clinical Interview for DSM-5 (SCID). 2. Prescription of benztropine or trihexyphenidyl for at least 6 months 3. Age 35-70 years. 4. ACBS score \>= 3. 5. Mild or absent extrapyramidal symptoms (Determined by clinical pharmacists and prescribers). 6. Competency and willingness to sign informed consent. Inclusion criteria for the healthy control group: 1. Age 40-70 years. 2. Competency and willingness to sign informed consent. Exclusion Criteria: 1. Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics, 2. 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). 3. Significant risk of suicidal or homicidal behavior. 4. Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent. 5. Contraindications for MR imaging (e.g., a pacemaker). 6. 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. 7. Patients concurrently treated with electroconvulsive therapy will be excluded because of its effects on cognition. Exclusion criteria for Healthy Control (HC) subjects: 1. No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP. 2. Score greater than 1 on the ACB scale. 3. MR imaging contraindications. 4. Neurologic conditions, any serious non-psychiatric disorder that could affect brain functioning, or intellectual disability. 5. HC with family history of psychosis will be excluded, as such individuals show subtle, but significant cognitive and neurobiological abnormalities. 6. Individuals currently taking anticholinergic medications for reasons other than SSD.
Study sites (1)
PA
- UPMC Western Psychiatric Hospital/University of Pittsburgh · Pittsburgh, PA 15213Tori Blazinski · Study contact · blazinskit2@upmc.eduDeepak K. Sarpal, M.D. · Principal investigatorShaun M. Eack, Ph.D. · Principal investigatorMore trials in Pittsburgh