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Could ditching a common drug sharpen the mind in schizophrenia?

NCT ID NCT06562608

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study looks at whether stopping unnecessary anticholinergic drugs (benztropine or trihexyphenidyl) can improve thinking, quality of life, and brain function in people aged 40-70 with schizophrenia or schizoaffective disorder. Participants will either stay on their medication or undergo deprescribing as part of routine care, with follow-ups over 6 months. The goal is to see if reducing these drugs leads to better cognitive performance and daily functioning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
benztropine or trihexyphenidyl (anticholinergic drugs)
What this could lead to
If successful, this could show that reducing unnecessary anticholinergic medications improves cognitive function and daily living in older adults with schizophrenia.
What could go wrong
This is a small Phase 4 study with 105 participants, so results may not apply broadly. Deprescribing may not lead to significant improvements, and some participants might experience withdrawal or return of side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Primary DSM-defined diagnosis of schizophrenia, schizoaffective disorder, or unspecified psychotic disorder, verified by the Structured Clinical Interview for DSM-5 (SCID). 2. Prescription of benztropine or trihexyphenidyl for at least 6 months 3. Age 35-70 years. 4. ACBS score \>= 3. 5. Mild or absent extrapyramidal symptoms (Determined by clinical pharmacists and prescribers). 6. Competency and willingness to sign informed consent. Inclusion criteria for the healthy control group: 1. Age 40-70 years. 2. Competency and willingness to sign informed consent. Exclusion Criteria: 1. Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics, 2. 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). 3. Significant risk of suicidal or homicidal behavior. 4. Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent. 5. Contraindications for MR imaging (e.g., a pacemaker). 6. 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. 7. Patients concurrently treated with electroconvulsive therapy will be excluded because of its effects on cognition. Exclusion criteria for Healthy Control (HC) subjects: 1. No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP. 2. Score greater than 1 on the ACB scale. 3. MR imaging contraindications. 4. Neurologic conditions, any serious non-psychiatric disorder that could affect brain functioning, or intellectual disability. 5. HC with family history of psychosis will be excluded, as such individuals show subtle, but significant cognitive and neurobiological abnormalities. 6. Individuals currently taking anticholinergic medications for reasons other than SSD.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UPMC Western Psychiatric Hospital/University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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