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Search / Trial NCT07043803

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

Launched by UNIVERSITY OF PITTSBURGH · Jun 20, 2025

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Schizophrenia Implementation Study Serious Mental Illness Psychiatric Disorders Anticholinergic Medication Deprescription Anticholinergic Side Effects Quality Of Life

ClinConnect Summary

This clinical trial is looking at ways to safely reduce the use of certain medications called anticholinergic medications (ACMs) in people with serious mental health conditions like schizophrenia, schizoaffective disorder, or bipolar disorder. These medications are often used to manage side effects from antipsychotic drugs, but sometimes they may no longer be needed. The goal is to see if it’s possible to lower or stop these medications without causing problems, helping patients avoid unnecessary medicines.

To take part, you must be 18 or older, have a confirmed diagnosis of one of these mental health conditions, and have been taking both antipsychotic and anticholinergic medications for at least six months. You also need to be considered stable by your healthcare team for at least three months, meaning your symptoms are under control. During the study, your healthcare providers will carefully check that your movement symptoms, which these anticholinergic drugs help with, are not severe. If you qualify and join, you can expect your doctors to work with you to gradually reduce these medications while monitoring your health closely to keep you safe and comfortable throughout the process.

Gender

ALL

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.

About University Of Pittsburgh

The University of Pittsburgh is a leading research institution known for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a robust infrastructure for research and a multidisciplinary approach, the university fosters collaboration among experts in various fields, facilitating the development of novel therapies and interventions. Its clinical trial programs emphasize ethical standards, patient safety, and the integration of cutting-edge technology, making the University of Pittsburgh a pivotal contributor to the landscape of clinical research and a trusted partner in the pursuit of health advancements.

Locations

Altoona, Pennsylvania, United States

Erie, Pennsylvania, United States

Mckeesport, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Professor of Psychiatry, MD

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported