Schizophenia DisorderRAMPNCT07043803
Reduction of Anticholinergic Medications Among Persons With Schizophrenia or Other Psychiatric Disorders
A study testing Reduction of anticholinergic medication in people with Schizophenia Disorder and Schizoaffective Disorder, run by University of Pittsburgh at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophenia Disorder, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- Reduction of anticholinergic medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Jul 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Western Behavioral Health of the Alleghenies
Altoona, Pennsylvania, 16601
UPMC Western Behavioral Health at Safe Harbor
Erie, Pennsylvania, 16508
Western Behavioral Health Mon Yough
McKeesport, Pennsylvania, 16601
Comprehensive Recovery Services (Pittsburgh) of Western Psychiatric Hospital, Ambulatory Clinics and Residential Programs - UPMC, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
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.
Read the 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.
- Being tested
- Reduction of anticholinergic medication
- Keywords
- schizophrenia, implementation study, serious mental illness, psychiatric disorders, anticholinergic medication deprescription, anticholinergic side effects, Quality of life
- Medical subject headings
- Psychotic Disorders, Bipolar Disorder, Mental Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction of anticholinergic medicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Anticholinergic Medication Reduction | Other | Not described Receives: Other: Reduction of anticholinergic medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Memory Impairment Screen (MIS) is being used to assess auditory verbal learning and free or cued recall memory. Lower scores are indicative of poorer learning and memory; the total scores range from 0 to 8. Scores of 5 through 8 generally indicate no memory impairment, scores of 4 or lower indicate memory concerns.
Measured: 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)
This is a self-report scale guided by clinicians for participants to fill out regarding the occurrence of side effects which may be associated with anticholinergic medications like benztropine and/or trihexyphenidyl. These include symptoms such as dry mouth, blurred vision, difficulty urinating, constipation, fast heartbeat or confusion/memory problems. Each item is anchored to the last week for recall by the patient and is rated from 0 (no side effects) to 6 (all the time and every day). The total score is computed by adding the 6 items, and ranges from a score of zero (none) to 36 (maximum), higher scores indicate worse anticholinergic effects. The last two items, intensity (overall severity, considering the six individual items), and impact on day-to-day functioning, are also scored 0 (none) to 6, 6 being intolerable or unable to function. The last two items are computed separately from the top 6 individual items and range from 0 (none) to 12 (severe or intolerable).
Measured: 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)
This widely used scale provides a score of the anticholinergic medication burden in an individual participant, and the potential impact on cognition in an individual patient. The scale was developed by expert consensus and is based on clinical evidence of an individual anticholinergic medication's impact on cognition either from the literature, or in vivo or in vitro data, or available data from the manufacturer, and/or the ability to induce delirium. Each medication is scored from a minimum of 1 to a maximum of 3, with 3 indicating highly anticholinergic medications (e.g. benztropine or trihexyphenidyl). The scale authors have suggested a score of 3 or greater is clinically significant for anticholinergic impact on cognition. For purposes of this clinical study, in addition to the original list of anticholinergic medications, the investigators have added an updated medication list (following market approval of psychotropic drugs) to the original list with anticholinergic properties.
Measured: Enrollment to final visit which can vary for each participant after Visit 1 (baseline) and can be up to 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start16 Jul 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Schizophenia DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, K.N. Roy Chengappa, University of Pittsburgh
- Investigators
- Professor of Psychiatry, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043803
- Sponsor's protocol ID
- STUDY24120064
- Other IDs
- UL1TR001857
- Acronym
- RAMP
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33878282Lupu 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.
PubMed 29178683
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07043803
- Acronym / sponsor ID
- RAMP / STUDY24120064
- Keywords
- schizophrenia, implementation study, serious mental illness, psychiatric disorders, anticholinergic medication deprescription, anticholinergic side effects, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), University of Pittsburgh Medical Center
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Anticholinergic Medication Reduction | Other | Other: Reduction of anticholinergic medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduction of anticholinergic medicationShared 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. | Other | Anticholinergic Medication Reduction |
Primary outcome
Reduction of Anticholinergic Medications
Time frame: 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.
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.
3 secondary outcomes
Auditory Verbal Learning and Recall
Time frame: 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)
Time frame: 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)
Time frame: Enrollment to final visit which can vary for each participant after Visit 1 (baseline) and can be up to 16 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 33878282Lupu 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.
- Background: PubMed 29178683Lupu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor of Psychiatry, MD principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction of anticholinergic medication in people with Schizophenia Disorder and Schizoaffective Disorder, run by University of Pittsburgh at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Anticholinergic Medications (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07043803, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.