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RecruitingAccepts healthy volunteersPhase 4

Anticholinergic Deprescription in Schizophrenia

Deepak K. Sarpal, M.D. · with National Institute of Mental Health (NIMH) · NCT06562608

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–70 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
105
US sites recruiting
1
Study start
February 1, 2025
Record last updated
July 10, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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

Being studied: Anticholinergic Deprescription; No Anticholinergic Deprescription

Conditions: Schizophrenia; Schizoaffective Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Inclusion criteria for the healthy control group:

  • Age 40-70 years.
  • 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.

Exclusion criteria for Healthy Control (HC) subjects:

  • No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP.
  • Score greater than 1 on the ACB scale.
  • MR imaging contraindications.
  • Neurologic conditions, any serious non-psychiatric disorder that could affect brain functioning, or intellectual disability.
  • HC with family history of psychosis will be excluded, as such individuals show subtle, but significant cognitive and neurobiological abnormalities.
  • Individuals currently taking anticholinergic medications for reasons other than SSD.

Recruiting US locations

  • UPMC Western Psychiatric Hospital/University of Pittsburgh

    Pittsburgh, PA 15213

    Site contact: Tori Blazinski · blazinskit2@upmc.edu

Study contacts (from the official record)

  • Deepak K Sarpal, M.D. · 4122465618 · sarpaldk@upmc.edu
  • Shaun M. Eack, Ph.D. · 412.648.9029 · sme12@pitt.edu
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Anticholinergic Deprescription in Schizophrenia (NCT06562608) | Bored Studies