SchizophreniaPhase 4NCT06562608
Anticholinergic Deprescription in Schizophrenia
A Phase 4 study testing Anticholinergic Deprescription and No Anticholinergic Deprescription in people with Schizophrenia and Schizoaffective Disorder, run by Deepak K. Sarpal, M.D. at 1 site in United States.
Trial summary
In this study, the investigators will examine whether a deprescription of unnecessary anticholinergic drugs (benztropine or trihexyphenidyl) can augment quality of life, functioning, and neurocognition in individuals who with schizophrenia. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Anticholinergic Deprescription and No Anticholinergic Deprescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary DSM-defined diagnosis of schizophrenia, schizoaffective disorder, or unspecified psychotic disorder, verified by the Structured Clinical Interview for DSM-5 (SCID).
- Prescription of benztropine or trihexyphenidyl for at least 6 months
- Age 35-70 years.
- ACBS score >= 3.
- Mild or absent extrapyramidal symptoms (Determined by clinical pharmacists and prescribers).
- Competency and willingness to sign informed consent.
- Age 40-70 years.
- Competency and willingness to sign informed consent.
Who cannot join
- Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics,
- Serious neurologic or medical condition/treatment that impacts the brain and Neurodegenerative conditions such as Parkinson's, dementia, etc.; autoimmune conditions such as Multiple Sclerosis (MS) and lupus; as well as traumatic brain injury (TBI).
- Significant risk of suicidal or homicidal behavior.
- Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.
- Contraindications for MR imaging (e.g., a pacemaker).
- Current SCID-verified substance use disorder will be excluded to avoid the confounding impact of significant substance use comorbidity. Participants with a history of substance use disorder that is in early or full remission will be eligible, to enhance generalizability.
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- Patients concurrently treated with electroconvulsive therapy will be excluded because of its effects on cognition.
- No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP.
- Score greater than 1 on the ACB scale.
- MR imaging contraindications.
- Neurologic conditions, any serious non-psychiatric disorder that could affect brain functioning, or intellectual disability.
- HC with family history of psychosis will be excluded, as such individuals show subtle, but significant cognitive and neurobiological abnormalities.
- Individuals currently taking anticholinergic medications for reasons other than SSD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Western Psychiatric Hospital/University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Tori Blazinski, blazinskit2@upmc.edu
Deepak K. Sarpal, M.D.
About this study
Official title: Neural Mechanisms of Anticholinergic Burden in Mid- to Late-Life Schizophrenia Spectrum
In this study, the investigators will examine whether a deprescription of unnecessary anticholinergic drugs (benztropine or trihexyphenidyl) can augment quality of life, functioning, and neurocognition in individuals who with schizophrenia. Individuals identified by clinical services who have unneeded prescriptions benztropine or trihexyphenidyl will be eligible for deprescription and study entry. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will will be randomized to either staying on their anticholinergic drugs or undergoing deprescription per routine clinical care, and will undergo follow-up evaluations across 6 months. The investigators predict that reducing and deprescribing these drug, if clinically determined to be unnecessary will will enhance functioning, neurocognition
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Anticholinergic Deprescription, No Anticholinergic Deprescription
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticholinergic DeprescriptionDrug
per routine clinical care, people in the active arm of the study will undergo deprescription of benztropine or trihexyphenidyl per routine clinical care.
No Anticholinergic DeprescriptionDrug
In this arm, no deprescription of benztropine or trihexyphenidyl will occur.
| Study group | Role | What they receive |
|---|---|---|
| Anticholinergic Deprescription | Experimental | In this arm, clinically determined unneeded benztropine or trihexyphenidyl will be deprescribed, per routine care by clinical providers. Receives: Drug: Anticholinergic Deprescription |
| No Anticholinergic Deprescription | Active comparator | In this arm, no deprescription of benztropine or trihexyphenidyl will occur. Receives: Drug: No Anticholinergic Deprescription |
| Healthy Controls | No intervention | In this arm, a healthy control group with minimal anticholinergic burden will be examined longitudinally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive performance
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in cognitive performance via scores from the MATRICS Consensus Cognitive Battery.
Measured: 6 months
Change in scores on quality of life assessments.
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in quality of life, measured with the WHOQOL-BREF.
Measured: 6 months
Change in scores on functional outcome assessments.
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in functional outcomes, measured with the Specific Level of Functioning Scale.
Measured: 6 months
change in brain functional connectivity.
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in brain functional connectivity between the basal forebrain and linked structures, such as regions of the cognitive control network, and the globus pallidus.
Measured: 6 months
change in activation of neurocognitive networks
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in brain activation of the cognitive control network via the AX-CPT, and activation of the hippocampus during memory encoding/retrieval via the Relational and Item-Specific Encoding task.
Measured: 6 months
Brain glutamate concentration
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in brain glutamate concentrations in the hippocampus and the dorsal anterior cingulate cortex.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Feb 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deepak K. Sarpal, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Deepak K. Sarpal, M.D., University of Pittsburgh
- Investigators
- Deepak K Sarpal, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562608
- Sponsor's protocol ID
- STUDY24050090
- Other IDs
- R01MH135096
- Status last verified
- Jul 2026
- First submitted
- 16 Aug 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data to the National Institute of Mental Health (NIMH) data archive
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Anticholinergic Burden in Mid- to Late-Life Schizophrenia Spectrum
- ClinicalTrials.gov ID
- NCT06562608
- Acronym / sponsor ID
- STUDY24050090
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Deepak K. Sarpal, M.D.University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 20 Aug 2024 (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.
In this study, the investigators will examine whether a deprescription of unnecessary anticholinergic drugs (benztropine or trihexyphenidyl) can augment quality of life, functioning, and neurocognition in individuals who with schizophrenia. Individuals identified by clinical services who have unneeded prescriptions benztropine or trihexyphenidyl will be eligible for deprescription and study entry. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will will be randomized to either staying on their anticholinergic drugs or undergoing deprescription per routine clinical care, and will undergo follow-up evaluations across 6 months. The investigators predict that reducing and deprescribing these drug, if clinically determined to be unnecessary will will enhance functioning, neurocognition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anticholinergic Deprescription | Experimental | Drug: Anticholinergic DeprescriptionIn this arm, clinically determined unneeded benztropine or trihexyphenidyl will be deprescribed, per routine care by clinical providers. |
| No Anticholinergic Deprescription | Active comparator | Drug: No Anticholinergic DeprescriptionIn this arm, no deprescription of benztropine or trihexyphenidyl will occur. |
| Healthy Controls | No intervention | –In this arm, a healthy control group with minimal anticholinergic burden will be examined longitudinally. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary DSM-defined diagnosis of schizophrenia, schizoaffective disorder, or unspecified psychotic disorder, verified by the Structured Clinical Interview for DSM-5 (SCID).
- Prescription of benztropine or trihexyphenidyl for at least 6 months
- Age 35-70 years.
- ACBS score >= 3.
- Mild or absent extrapyramidal symptoms (Determined by clinical pharmacists and prescribers).
Key exclusion criteria (13 listed)
- Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics,
- Serious neurologic or medical condition/treatment that impacts the brain and Neurodegenerative conditions such as Parkinson's, dementia, etc.; autoimmune conditions such as Multiple Sclerosis (MS) and lupus; as well as traumatic brain injury (TBI).
- Significant risk of suicidal or homicidal behavior.
- Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.
- Contraindications for MR imaging (e.g., a pacemaker).
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 |
|---|---|---|
| Anticholinergic Deprescriptionper routine clinical care, people in the active arm of the study will undergo deprescription of benztropine or trihexyphenidyl per routine clinical care. | Drug | Anticholinergic Deprescription |
| No Anticholinergic DeprescriptionIn this arm, no deprescription of benztropine or trihexyphenidyl will occur. | Drug | No Anticholinergic Deprescription |
Primary outcome
Change in cognitive performance
Time frame: 6 months
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in cognitive performance via scores from the MATRICS Consensus Cognitive Battery.
Change in scores on quality of life assessments.
Time frame: 6 months
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in quality of life, measured with the WHOQOL-BREF.
Change in scores on functional outcome assessments.
Time frame: 6 months
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in functional outcomes, measured with the Specific Level of Functioning Scale.
change in brain functional connectivity.
Time frame: 6 months
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in brain functional connectivity between the basal forebrain and linked structures, such as regions of the cognitive control network, and the globus pallidus.
change in activation of neurocognitive networks
Time frame: 6 months
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in brain activation of the cognitive control network via the AX-CPT, and activation of the hippocampus during memory encoding/retrieval via the Relational and Item-Specific Encoding task.
Brain glutamate concentration
Time frame: 6 months
We will examine whether the anticholinergic deprescription group, relative to the non-deprescription group, shows an increase in brain glutamate concentrations in the hippocampus and the dorsal anterior cingulate cortex.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data to the National Institute of Mental Health (NIMH) data archive
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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.
Deepak K Sarpal, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anticholinergic Deprescription and No Anticholinergic Deprescription in people with Schizophrenia and Schizoaffective Disorder, run by Deepak K. Sarpal, M.D. at 1 site 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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deepak K Sarpal, M.D. (4122465618, sarpaldk@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive performance (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.