NCT06562608RecruitingPhase 4
Anticholinergic Deprescription in Schizophrenia
Neural Mechanisms of Anticholinergic Burden in Mid- to Late-Life Schizophrenia Spectrum
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 16 Aug 2024
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Deepak K. Sarpal, M.D.
- Diseases
- Schizophrenia
- NCT number
- NCT06562608
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 105
- From 1 Feb 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients concurrently treated with electroconvulsive therapy will be excluded because of its effects on cognition.
- Individuals currently taking anticholinergic medications for reasons other than SSD.
Other illness
- 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).
- 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.
- No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP.
- 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.
Other
- Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics,
- 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).
- Score greater than 1 on the ACB scale.
- MR imaging contraindications.
Who the study is looking for
- 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.
- Age 40-70 years.
- Competency and willingness to sign informed consent.
Age in the registry: 40 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC Western Psychiatric Hospital/University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.