Reduction of Anticholinergic Medications Among Persons With Schizophrenia or Other Psychiatric Disorders

NCT ID: NCT07043803

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-16
• Study Completion Date: 2026-05-31

Brief 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.

Detailed Description

Based on the investigator's preliminary work, the investigators will utilize a combination of administrative, prescriber and patient buy-in to reduce Anticholinergic Medication (ACM), when these medications are no longer needed, as evidence-based practice. Previously developed materials and tools from the investigator's earlier work include an ACM side-effect scale (the Pittsburgh Anticholinergic Symptoms Scale, PASS v2.0), a patient-facing information leaflet reviewing the risks of long-term ACM use, and a Clinical Guide for deprescribing. These, as well as education on the Anticholinergic Medication Burden (ACMB) reduction protocol will be provided to prescribers at initiation of each site. The clinical pharmacist on the team will train staff at each site to compute and record the Anticholinergic Cognitive Burden and use the PASS to assess ACM side effects. The investigators will train the staff members to administer the Memory Impairment Screen, a verbal working memory task.

The Principal Investigator (PI) and members of the study team will work with the healthcare teams at each site using case examples of 'how to reduce and/or stop anticholinergic medications" and maintain office hours on a scheduled basis to problem-solve, trouble-shoot and/or manage the medication reduction process and clinical issues that emerge. The PI and members of the study team will train the healthcare teams at each site to examine eligible patients for extra pyramidal symptoms and in the use of a shared decision-making approach in this effort to reduce anticholinergic medications.

Based on considerable interest from our healthcare partners, and in the absence of any randomized studies, the investigators intend to use a stepped-wedge, randomized trial study design to implement this protocol for eligible patients in each of the participating clinics. In addition to affirming earlier positive clinical outcomes in the preliminary work, the investigators intend to assess barriers to and facilitators of anticholinergic medication burden reduction implementation to inform the emerging evidence-based practice.

Conditions

Schizophenia Disorder; Schizoaffective Disorder; Bipolar Disorder; Psychiatric Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Anticholinergic Medication Reduction

Group Type: OTHER

Reduction of anticholinergic medication

Intervention Type: OTHER

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.

Interventions

Reduction of anticholinergic medication

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. are 18 years or older

2. have a chart DSM V diagnosis of schizophrenia spectrum or schizoaffective or bipolar disorder or any other mental illness disorder

3. have received ACM and antipsychotic medications for 6 months or more

4. are considered to be clinically stable (by the patient's healthcare team) for 3 months or more

5. the ACM (e.g. benztropine and/or trihexyphenidyl) is being used to treat EPS associated with antipsychotic medications.

6. 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.

7. able and willing to sign the approved informed consent document.

Exclusion Criteria

1. patients with ongoing Parkinsonian symptoms who require ACM meds for countering EPS side effects based on the Simpson-Angus Scale score cutoffs.

2. 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.

3. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

K.N. Roy Chengappa

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Professor of Psychiatry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Western Behavioral Health of the Alleghenies

Altoona, Pennsylvania, United States

Site Status: NOT_YET_RECRUITING

UPMC Western Behavioral Health at Safe Harbor

Erie, Pennsylvania, United States

Site Status: RECRUITING

Western Behavioral Health Mon Yough

McKeesport, Pennsylvania, United States

Site Status: NOT_YET_RECRUITING

Comprehensive Recovery Services (Pittsburgh) of Western Psychiatric Hospital, Ambulatory Clinics and Residential Programs - UPMC, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Administrative Coordinator

Role: CONTACT

spinogattij@upmc.edu

4122465006

Professor of Psychiatry, MD

Role: CONTACT

chengappakn@upmc.edu

412-246-5006

Facility Contacts

Administrative Coordinator

Role: primary

spinogattij@upmc.edu

412-246-5006

Administrative Coordinator

Role: primary

spinogattij@upmc.edu

412-246-5006

Administrative Coordinator

Role: primary

spinogattij@upmc.edu

412-246-5006

Administrative Coordinator

Role: primary

spinogattij@upmc.edu

412-246-5006

References

Lupu AM, MacCamy KL, Gannon JM, Brar JS, Chengappa KNR. Less is more: Deprescribing anticholinergic medications in persons with severe mental illness. Ann Clin Psychiatry. 2021 May;33(2):80-92. doi: 10.12788/acp.0019. Epub 2021 Feb 1.

Reference Type: BACKGROUND

PMID: 33878282 (View on PubMed)

Lupu AM, Clinebell K, Gannon JM, Ellison JC, Chengappa KNR. Reducing Anticholinergic Medication Burden in Patients With Psychotic or Bipolar Disorders. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1270-e1275. doi: 10.4088/JCP.16m11269.

Reference Type: BACKGROUND

PMID: 29178683 (View on PubMed)

Other Identifiers

UL1TR001857

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY24120064

Identifier Type: -

Identifier Source: org_study_id