Reduction of Anticholinergic Medications Among Persons With Schizophrenia or Other Psychiatric Disorders
Reduction of Anticholinergic Medications Project (RAMP) Among Persons With Schizophrenia or Other Psychiatric Disorders Across UPMC Behavioral Healthcare Partner Organizations Using a Stepped-wedge, Randomized Trial Study Design.
University of Pittsburgh
111 participants
Jul 16, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this study is to reduce Anticholinergic Medication (ACM) in persons with psychoses or serious mental illness, when these medications are no longer needed.
Eligibility
Inclusion Criteria7
- are 18 years or older
- have a chart DSM V diagnosis of schizophrenia spectrum or schizoaffective or bipolar disorder or any other mental illness disorder
- have received ACM and antipsychotic medications for 6 months or more
- are considered to be clinically stable (by the patient's healthcare team) for 3 months or more
- the ACM (e.g. benztropine and/or trihexyphenidyl) is being used to treat EPS associated with antipsychotic medications.
- on an examination using the modified Simpson-Angus Extrapyramidal Symptoms Scale (head dropping and leg pendulousness items are dropped), no single item rated at 3 or 4.
- able and willing to sign the approved informed consent document.
Exclusion Criteria3
- patients with ongoing Parkinsonian symptoms who require ACM meds for countering EPS side effects based on the Simpson-Angus Scale score cutoffs.
- if the clinicians treating the potentially eligible patients consider them to be clinically unstable or if drug-addiction is the focus of treatment and participation in ACM de-prescription protocols is considered risky, the team will defer to the treating clinicians to exclude participants.
- The same exclusions will apply to those persons undergoing medical procedures and treatments that make participation in this ACM deprescription trial unwise per the treating team.
Interventions
Shared decision making between the patient and prescriber will determine the timing and speed of reduction over a period of 12 to 16 weeks. Some patients will be discontinued from these anticholinergic medications (benztropine/trihexyphenidyl), others will be tapered from their original dosage but not completely discontinued, and some patients may not be able to taper the anticholinergic medications at all.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07043803