Anticholinergic Deprescription in Schizophrenia (NCT06562608) | Clinical Trial Compass
RecruitingPhase 4
Anticholinergic Deprescription in Schizophrenia
United States105 participantsStarted 2025-02-01
Plain-language 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 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
Who can participate
Age range40 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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).
What they're measuring
1
Change in cognitive performance
Timeframe: 6 months
2
Change in scores on quality of life assessments.
Timeframe: 6 months
3
Change in scores on functional outcome assessments.
✕. 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.
✕. No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP.