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Purpose

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

Eligibility

Eligible Ages
Between 40 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Primary DSM-defined diagnosis of schizophrenia or schizoaffective disorder verified by the Structured Clinical Interview for DSM-5 (SCID). 2. Prescription of benztropine or trihexyphenidyl for at least 6 months 3. Age 40-70 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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Anticholinergic Deprescription 		In this arm, clinically determined unneeded benztropine or trihexyphenidyl will be deprescribed, per routine care by clinical providers.
  • Drug: Anticholinergic Deprescription
    per routine clinical care, people in the active arm of the study will undergo deprescription of benztropine or trihexyphenidyl per routine clinical care.
  • Drug: No Anticholinergic Deprescription
    In this arm, no deprescription of benztropine or trihexyphenidyl will occur.
Active Comparator
No Anticholinergic Deprescription 		In this arm, no deprescription of benztropine or trihexyphenidyl will occur.
  • Drug: No Anticholinergic Deprescription
    In this arm, no deprescription of benztropine or trihexyphenidyl will occur.
No Intervention
Healthy Controls 		In this arm, a healthy control group with minimal anticholinergic burden will be examined longitudinally.

Recruiting Locations

UPMC Western Psychiatric Hospital/University of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15213
Contact:
Tori Blazinski
blazinskit2@upmc.edu

More Details

Status
Recruiting
Sponsor
Deepak K. Sarpal, M.D.

Study Contact

Deepak K Sarpal, M.D.
4122465618
sarpaldk@upmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.