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Recruiting NCT06562608

Anticholinergic Deprescription in Schizophrenia

Phase IV Interventional Schizophrenia Schizoaffective Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anticholinergic Deprescription, No Anticholinergic Deprescription.
Who it may be relevant to
Registry conditions: Schizophrenia, Schizoaffective Disorder. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neural Mechanisms of Anticholinergic Burden in Mid- to Late-Life Schizophrenia Spectrum

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Change in cognitive performance [Time frame: 6 months]
  • Change in scores on quality of life assessments. [Time frame: 6 months]
  • Change in scores on functional outcome assessments. [Time frame: 6 months]
  • change in brain functional connectivity. [Time frame: 6 months]
  • change in activation of neurocognitive networks [Time frame: 6 months]
  • Brain glutamate concentration [Time frame: 6 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UPMC Western Psychiatric Hospital/University of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT06562608 · STUDY24050090 · R01MH135096

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗