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

NCT07043803 | Active Not Recruiting DMC

• 2 other identifiers: STUDY24120064UL1TR001857
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 4

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.

Conditions

Schizophenia Disorder; Bipolar Disorder; Schizoaffective Disorder; Psychiatric Disorders

Keywords

schizophrenia; implementation study; serious mental illness; psychiatric disorders; anticholinergic medication deprescription; anticholinergic side effects; Quality of life

Outcome Measures

Primary Outcomes (1)

• Reduction of Anticholinergic Medications

  For the primary outcome, reduction of anticholinergic medications (benztropine and/or trihexyphenidyl) will be computed as a percentage reduction from baseline. Those participants who discontinued fully will be considered as having a 100% reduction, and those who tapered but did not discontinue will be computed as a percentage reduction from baseline, and those participants who did not discontinue at all will be considered to have a zero-percentage reduction. This anticholinergic medication reduction will be computed at the end of the study for each participant and summed for all study participants.

  From enrollment to final visit. The final visit can vary for each participant and can be up to 16 weeks following the first baseline visit.

Secondary Outcomes (3)

• Auditory Verbal Learning and Recall

  Enrollment to final visit. This can vary for each participant after Visit 1 (baseline) and be up to 16 weeks.

• The Pittsburgh Anticholinergic Symptoms Scale v2.0 (PASS)

  Enrollment to final visit which can vary for each participant after Visit 1 (baseline) and can be up to 16 weeks.

• Anticholinergic Cognitive Burden Scale (ACB)

  Enrollment to final visit which can vary for each participant after Visit 1 (baseline) and can be up to 16 weeks.

Study Arms (1)

Anticholinergic Medication Reduction

OTHER

Other: Reduction of anticholinergic medication

Interventions

Reduction of anticholinergic medication 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.

Anticholinergic Medication Reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh Medical Center: collaborator
• University of Pittsburgh: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (4)

Western Behavioral Health of the Alleghenies

Altoona, Pennsylvania, 16601, United States

Location

UPMC Western Behavioral Health at Safe Harbor

Erie, Pennsylvania, 16508, United States

Location

Western Behavioral Health Mon Yough

McKeesport, Pennsylvania, 16601, United States

Location

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

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 33878282 BACKGROUND

• 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.

  PMID: 29178683 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Bipolar Disorder; Mental Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Professor of Psychiatry, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: The investigators will use a stepped-wedge open-cohort single arm trial design, where each of the four sites is randomized 2 to 6 weeks apart.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: July 16, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)