Clinical trial for Schizophrenia
Official title Anticholinergic Deprescription in Schizophrenia
ClinicalTrials.gov ID: NCT06562608
What this study is testing
What is Anticholinergic Deprescription?
investigational deprescription of anticholinergic drugs being studied to improve quality of life, functioning, and neurocognition in schizophrenia
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether stopping unnecessary anticholinergic drugs improves quality of life, daily functioning, and thinking in people with schizophrenia or schizoaffective disorder.
- Who it's for
- You may be able to join if you have schizophrenia or schizoaffective disorder and are taking benztropine or trihexyphenidyl that your doctor thinks may not be needed.
- What's involved
- You will be randomly assigned, like a coin toss, to keep the medicine or to stop it under doctor supervision. You will have clinic visits and tests, including an MRI, over six months.
- Time commitment
- The study lasts about six months with several clinic visits and an MRI at the start.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Primary DSM-defined diagnosis of schizophrenia, schizoaffective disorder, or unspecified psychotic disorder, verified by the Structured Clinical...
- 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).
You likely can't join if
- 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.
- Significant risk of suicidal or homicidal behavior.
- Cognitive or language limitations, or any other factor that would preclude people 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.
See the full eligibility criteria
- 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).
- Age 40-70 years.
- Competency and willingness to sign informed consent.
- 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
- Significant risk of suicidal or homicidal behavior.
- Cognitive or language limitations, or any other factor that would preclude people 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.