Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH135096 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anticholinergic Deprescription | Experimental | In this arm, clinically determined unneeded benztropine or trihexyphenidyl will be deprescribed, per routine care by clinical providers. |
|
| No Anticholinergic Deprescription | Active Comparator | In 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticholinergic Deprescription | Drug | per routine clinical care, people in the active arm of the study will undergo deprescription of benztropine or trihexyphenidyl per routine clinical care. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 6 months |
| Brain glutamate concentration |
Not provided
Not provided
Inclusion Criteria:
Inclusion criteria for the healthy control group:
Exclusion Criteria:
Exclusion criteria for Healthy Control (HC) subjects:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deepak K Sarpal, M.D. | Contact | 4122465618 | sarpaldk@upmc.edu | |
| Shaun M. Eack, Ph.D. | Contact | 412.648.9029 | sme12@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Deepak K Sarpal, M.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Western Psychiatric Hospital/University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
De-identified individual participant data to the National Institute of Mental Health (NIMH) data archive
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No Anticholinergic Deprescription | Drug | In this arm, no deprescription of benztropine or trihexyphenidyl will occur. |
|
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.
| 6 months |