Status:
RECRUITING
Anticholinergic Deprescription in Schizophrenia
Lead Sponsor:
Deepak K. Sarpal, M.D.
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
40-70 years
Phase:
PHASE4
Brief Summary
In this study, the investigators will examine whether a deprescription of unnecessary anticholinergic drugs (benztropine or trihexyphenidyl) can augment quality of life, functioning, and neurocognitio...
Eligibility Criteria
Inclusion
- Primary DSM-defined diagnosis of schizophrenia or schizoaffective disorder verified by the Structured Clinical Interview for DSM-5 (SCID).
- Prescription of benztropine or trihexyphenidyl for at least 6 months
- Age 40-70 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
- 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.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06562608
Start Date
February 1 2025
End Date
June 30 2029
Last Update
February 10 2025
Active Locations (1)
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1
UPMC Western Psychiatric Hospital/University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213