Anticholinergic Deprescription in Schizophrenia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-70
SponsorDeepak K. Sarpal, M.D.
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Anticholinergic Deprescription
Drugper routine clinical care, people in the active arm of the study will undergo deprescription of benztropine or trihexyphenidyl per routine clinical care.
No Anticholinergic Deprescription
DrugIn this arm, no deprescription of benztropine or trihexyphenidyl will occur.
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: Anticholinergic DeprescriptionExperimental treatment 1 intervention
Group B: No Anticholinergic DeprescriptionActive comparator 1 intervention
Group C: Healthy ControlsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months2
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.
Time frame
6 months3
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.
Time frame
6 months4
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.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Deepak K. Sarpal, M.D.
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov