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Anticholinergic Deprescription for Schizophrenia

Phase 4
Waitlist Available
Led By Deepak K Sarpal, M.D.
Research Sponsored by Deepak K. Sarpal, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prescription of benztropine or trihexyphenidyl for at least 6 months
Age 40-70 years
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

"This trial will investigate if stopping unnecessary anticholinergic drugs can improve the quality of life, functioning, and brain function in individuals with schizophrenia. Participants with unnecessary prescriptions of benztropine or tri

Who is the study for?
This trial is for individuals with schizophrenia, schizoaffective disorder, or psychosis who are currently prescribed anticholinergic drugs (benztropine or trihexyphenidyl) that may not be necessary. Participants will undergo evaluations and MRI scans.
What is being tested?
The study aims to see if stopping unnecessary anticholinergic medications can improve life quality, functioning, and brain function in patients with schizophrenia. Participants will either continue their medication or stop it under medical supervision over six months.
What are the potential side effects?
Potential side effects were not specified in the provided information. However, changes in medication regimens could lead to withdrawal symptoms or a return of previously managed symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been prescribed benztropine or trihexyphenidyl for 6 months or more.
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I am between 40 and 70 years old.
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I am between 40 and 70 years old.
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I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe side effects from anticholinergic drugs that require stopping them.
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I do not have Parkinson's, dementia, MS, lupus, or a history of traumatic brain injury.
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I do not have a family history of psychosis.
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I am not currently undergoing electroconvulsive therapy.
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I do not have any serious brain-related or intellectual disabilities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brain glutamate concentration
Change in cognitive performance
Change in scores on functional outcome assessments.
+3 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Anticholinergic DeprescriptionExperimental Treatment1 Intervention
In this arm, clinically determined unneeded benztropine or trihexyphenidyl will be deprescribed, per routine care by clinical providers.
Group II: Healthy ControlsActive Control1 Intervention
In this arm, a healthy control group with minimal anticholinergic burden will be examined longitudinally.
Group III: No Anticholinergic DeprescriptionActive Control1 Intervention
In this arm, no deprescription of benztropine or trihexyphenidyl will occur.

Find a Location

Who is running the clinical trial?

Deepak K. Sarpal, M.D.Lead Sponsor
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,860 Total Patients Enrolled
254 Trials studying Schizophrenia
89,926 Patients Enrolled for Schizophrenia
Deepak K Sarpal, M.D.Principal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Schizophrenia
30 Patients Enrolled for Schizophrenia
~70 spots leftby Dec 2028
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