RECRUITING

Anticholinergic Deprescription in Schizophrenia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-02-01
Study Completion:2029-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06562608

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Primary DSM-defined diagnosis of schizophrenia or schizoaffective disorder verified by the Structured Clinical Interview for DSM-5 (SCID).
  2. 2. Prescription of benztropine or trihexyphenidyl for at least 6 months
  3. 3. Age 40-70 years.
  4. 4. ACBS score \>= 3.
  5. 5. Mild or absent extrapyramidal symptoms (Determined by clinical pharmacists and prescribers).
  6. 6. Competency and willingness to sign informed consent.
  7. 1. Age 40-70 years.
  8. 2. Competency and willingness to sign informed consent.
  1. 1. Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics,
  2. 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. 3. Significant risk of suicidal or homicidal behavior.
  4. 4. Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.
  5. 5. Contraindications for MR imaging (e.g., a pacemaker).
  6. 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. 7. Patients concurrently treated with electroconvulsive therapy will be excluded because of its effects on cognition.
  8. 1. No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP.
  9. 2. Score greater than 1 on the ACB scale.
  10. 3. MR imaging contraindications.
  11. 4. Neurologic conditions, any serious non-psychiatric disorder that could affect brain functioning, or intellectual disability.
  12. 5. HC with family history of psychosis will be excluded, as such individuals show subtle, but significant cognitive and neurobiological abnormalities.
  13. 6. Individuals currently taking anticholinergic medications for reasons other than SSD.

Contacts and Locations

Study Contact

Deepak K Sarpal, M.D.
CONTACT
4122465618
sarpaldk@upmc.edu
Shaun M. Eack, Ph.D.
CONTACT
412.648.9029
sme12@pitt.edu

Principal Investigator

Deepak K Sarpal, M.D.
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

UPMC Western Psychiatric Hospital/University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Deepak K. Sarpal, M.D.

  • Deepak K Sarpal, M.D., PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01
Study Completion Date2029-06-30

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia
  • Schizoaffective Disorder