Reducing unnecessary anticholinergic medications in schizophrenia

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

This study tests if stopping unnecessary anticholinergic medications can help people with schizophrenia feel better and improve their daily functioning.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: University of Pittsburgh (other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT06562608 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of deprescribing unnecessary anticholinergic medications, specifically benztropine or trihexyphenidyl, in individuals diagnosed with schizophrenia or schizoaffective disorder. Participants will be randomized to either continue their current medication or undergo deprescription, following a baseline evaluation and MRI. The study aims to assess improvements in quality of life, functioning, and neurocognition over a six-month follow-up period. The hypothesis is that reducing these medications, when deemed unnecessary, will lead to enhanced patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-70 with a primary diagnosis of schizophrenia or schizoaffective disorder who have been on anticholinergic medications for at least six months.

Not a fit: Patients experiencing serious anticholinergic side effects or those with significant neurological or medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the quality of life and cognitive functioning for patients with schizophrenia by minimizing unnecessary medication use.

How similar studies have performed: While the specific approach of deprescribing anticholinergics in this context may be novel, there is a growing body of literature supporting the benefits of medication optimization in psychiatric care.

Eligibility criteria

Inclusion Criteria:

1. Primary DSM-defined diagnosis of schizophrenia or schizoaffective disorder verified by the Structured Clinical Interview for DSM-5 (SCID).
2. Prescription of benztropine or trihexyphenidyl for at least 6 months
3. Age 40-70 years.
4. ACBS score \>= 3.
5. Mild or absent extrapyramidal symptoms (Determined by clinical pharmacists and prescribers).
6. Competency and willingness to sign informed consent.

Inclusion criteria for the healthy control group:

1. Age 40-70 years.
2. Competency and willingness to sign informed consent.

Exclusion Criteria:

1. Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics,
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. Significant risk of suicidal or homicidal behavior.
4. Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.
5. Contraindications for MR imaging (e.g., a pacemaker).
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. Patients concurrently treated with electroconvulsive therapy will be excluded because of its effects on cognition.

Exclusion criteria for Healthy Control (HC) subjects:

1. No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP.
2. Score greater than 1 on the ACB scale.
3. MR imaging contraindications.
4. Neurologic conditions, any serious non-psychiatric disorder that could affect brain functioning, or intellectual disability.
5. HC with family history of psychosis will be excluded, as such individuals show subtle, but significant cognitive and neurobiological abnormalities.
6. Individuals currently taking anticholinergic medications for reasons other than SSD.

Where this trial is running

Pittsburgh, Pennsylvania

• UPMC Western Psychiatric Hospital/University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Deepak K Sarpal, M.D. — University of Pittsburgh
• Study coordinator: Deepak K Sarpal, M.D.

Conditions: Schizophrenia, Schizoaffective Disorder