Anticholinergic Deprescription for Schizophrenia
Recruiting in Palo Alto (17 mi)
Overseen ByDeepak K Sarpal, M.D.
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Deepak K. Sarpal, M.D.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of 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
Will I have to stop taking my current medications?
The trial focuses on stopping unnecessary anticholinergic drugs like benztropine or trihexyphenidyl for some participants. If you are taking these medications and they are deemed unnecessary, you might be asked to stop them as part of the study.
What data supports the effectiveness of anticholinergic deprescription for schizophrenia?
Some studies suggest that reducing anticholinergic drugs can improve the quality of life for patients with severe mental illness, as these drugs can cause side effects like dry mouth and cognitive issues. Additionally, anticholinergic drugs may worsen certain symptoms of schizophrenia, so deprescribing them might help in managing the condition better.
12345Is anticholinergic deprescription generally safe for humans?
Deprescribing anticholinergic medications, which are often used with antipsychotics, can reduce side effects like memory problems, dry mouth, and constipation, and may improve quality of life without causing the return of symptoms they were meant to treat.
45678How does anticholinergic deprescription differ from other treatments for schizophrenia?
Anticholinergic deprescription is unique because it involves reducing or stopping the use of anticholinergic drugs, which are often used to manage side effects of antipsychotic medications in schizophrenia. This approach aims to minimize the negative cognitive effects and potential for misuse associated with long-term anticholinergic use, unlike traditional treatments that focus on adding medications.
2591011Eligibility Criteria
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.Inclusion Criteria
I have been prescribed benztropine or trihexyphenidyl for 6 months or more.
I am between 40 and 70 years old.
I am between 40 and 70 years old.
I have been diagnosed with schizophrenia or schizoaffective disorder.
Exclusion Criteria
I have severe side effects from anticholinergic drugs that require stopping them.
I do not have Parkinson's, dementia, MS, lupus, or a history of traumatic brain injury.
I do not have a family history of psychosis.
I am not currently undergoing electroconvulsive therapy.
I do not have any serious brain-related or intellectual disabilities.
Participant Groups
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.
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 Clinic Near You
Research locations nearbySelect from list below to view details:
UPMC Western Psychiatric Hospital/University of PittsburghPittsburgh, PA
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Who is running the clinical trial?
Deepak K. Sarpal, M.D.Lead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Effect of anticholinergic medication on positive and negative symptoms in medication-free schizophrenic patients. [2019]It is generally assumed that anticholinergic drugs have no effects on schizophrenic symptomatology. A few studies, however, indicate that anticholinergic agents aggravate psychotic symptoms and antagonize therapeutic effects of neuroleptics in schizophrenic patients; more recently, some investigators have observed that these agents appear to benefit negative symptoms. In an effort to resolve this issue, we studied the effects of 2 days of treatment with biperiden on positive and negative symptoms in 15 medication-free schizophrenic patients. Positive symptoms increased significantly, while there was a trend toward a decrease in negative symptoms. The implications of these findings for the role of the cholinergic system in schizophrenia are discussed.
Excessive use of anticholinergic drugs in a sub-sample of Italian schizophrenics. [2013]Compliance to the prescription of anticholinergic drugs in 274 consecutive schizophrenic outpatients has been assessed retrospectively from their clinical records. Ten point four percent of the sample (22 patients) took these drugs in amounts greater than those prescribed. Some possible explanations of this excessive use are discussed.
Therapeutic antagonism between anticholinergic antiparkinsonism agents and neuroleptics in schizophrenia. Implications for a neuropharmacological model. [2018]Systematic data from three studies suggest that anticholinergic antiparkinsonism agents, when added to ongoing neuroleptic treatment in schizophrenics, have the effect of arresting or reversing therapeutic changes, and when given alone to untreated patients, tend to further worsen their psychosis. The countertherapeutic effects of anticholinergic drugs are reflected particularly in parameters which represent features of schizophrenic psychosis most consistently responsive to neuroleptics. It is proposed that these anticholinergic effects are central in origin and point to the involvement of cholinergic mechanisms in the expression of schizophrenic psychosis and its improvement with neuroleptic medication.
Reducing Anticholinergic Medication Burden in Patients With Psychotic or Bipolar Disorders. [2019]Anticholinergic medications are prescribed to treat extrapyramidal side effects (EPS) associated with antipsychotics. Anticholinergic medications cause several side effects and can often be withdrawn during the maintenance phase of antipsychotic treatment without EPS reemergence. The purpose of this quality improvement (QI) project was to reduce anticholinergic medication burden and improve quality of life in patients with severe mental illness.
Frequency and correlates of anticholinergic use among patients with schizophrenia in Denmark: A Nation-wide pharmacoepidemiological study. [2018]Anticholinergic medications are used to treat extrapyramidal adverse effects induced by antipsychotics. Anticholinergics are associated with adverse effects: constipation, dry mouth and worsening of cognitive function. Anticholinergics have potential for abuse and are not recommended for long term-treatment. We aimed to investigate the use of anticholinergics in patients with schizophrenia. The national health registers in Denmark were used to examine: The prevalence of anticholinergics in 1996-2012 using a cross-sectional design; geographic variations in the prescription of anticholinergics in 2012; correlates of treatment with anticholinergics. The proportion of patients using anticholinergics decreased significantly from 11.7% in 1996 to 5.7% in 2012. The prescription pattern varied considerably between national regions in 2012, ranging from 4.0% in the Capital Region to 8.1% in the Northern Denmark Region. Long-term use of anticholinergics was predicted by older age, age at debut of schizophrenia, receiving early retirement pension, typical antipsychotic use, antipsychotic polypharmacy, typical + atypical antipsychotics, antidepressant treatment, high doses of antipsychotics measured in defined-daily-dose, physical comorbidity and psychiatrists` greater caseload. Use of anticholinergics declined during the study period, and showed substantial variation across the regions in 2012. Long-term use was linked to typical antipsychotic use and variables that are associated with greater illness severity.
Less is more: Deprescribing anticholinergic medications in persons with severe mental illness. [2023]Long-term prescribing of anticholinergic medications (ACM) for antipsychotic-associated extrapyramidal symptoms (EPS) is not recommended, yet is widely prevalent. Adverse effects of ACM include memory impairment, dry mouth, constipation, blurred vision, urinary retention, and tachycardia, which can seriously impact quality of life. This quality improvement deprescription project sought to reduce chronic ACM use in patients with serious mental illness (SMI).
Severe adverse drug reactions in psychiatric inpatients treated with neuroleptics. [2007]Numerous studies compare side effects or adverse drug reactions (ADRs) of the various typical and newer atypical neuroleptics in patients with schizophrenia. However, these studies, as controlled randomized trials, represent an artificial setting of drug administration and do not easily relate to the "real-life" setting of psychiatric treatment. In contrast, the AMSP drug safety program allows the monitoring of ADRs of all types of psychopharmacological agents in the naturalistic setting of routine clinical practice. In the present study, the data on neuroleptics acquired in the AMSP program from 1993 to 2000 are analyzed. In this period, 86,439 patients treated with at least one neuroleptic agent were monitored. In 1.1 % of the patients severe ADRs occurred. In contrast to the results from controlled trials, atypical neuroleptics caused more severe ADRs than did typical neuroleptics. This result was mainly caused by the high number of severe ADRs in patients treated with clozapine and concerned delirium and non-EPS neurological, gastrointestinal, hepatic, dermatological, hematological, and endocrinological ADRs. Atypical neuroleptics were found to be superior in EPS and urological ADRs. Excluding the data on clozapine, we found typical and atypical neuroleptics to be similar in the occurrence of severe ADRs, although the profiles differ between these two groups as well as between the single substances. Our findings provide valuable information on the type and frequency of ADRs in psychiatric practice, thus enabling differential indication of neuroleptics based not only on the efficacy and tolerability data of controlled trials but also on their differential ADR profile occurring in the "real-life" setting of routine clinical treatment.
Deprescribing anticholinergic medication in the community mental health setting: A quality improvement initiative. [2021]Chronic anticholinergic medication (ACM) prescribing with antipsychotics when no longer clinically indicated can lead to serious side effects and adversely impact patient quality of life.
Anticholinergic burden in schizophrenia and ability to benefit from psychosocial treatment programmes: a 3-year prospective cohort study. [2018]Many medications administered to patients with schizophrenia possess anticholinergic properties. When aggregated, pharmacological treatments may result in a considerable anticholinergic burden. The extent to which anticholinergic burden has a deleterious effect on cognition and impairs ability to participate in and benefit from psychosocial treatments is unknown.
Cholinergic syndrome following anticholinergic withdrawal in a schizophrenic patient abusing marijuana. [2019]A 27-year-old neuroleptic-stabilised schizophrenic patient presented with a three-day history of psychomotor retardation, disturbed sleep, and social and emotional withdrawal following reduction of his anticholinergic dosage; his symptoms had intensified after an increase in neuroleptic dosage, based on a diagnosis of psychotic decompensation. Recognition of a cholinergic syndrome and institution of appropriate anticholinergic treatment resulted in rapid improvement. The clinical distinction between a cholinergic overdrive state and schizophrenic exacerbation, while sometimes difficult, can be critical in selecting appropriate management.
Biperiden dependence: case report and literature review. [2021]Anticholinergic drugs are frequently used in psychiatry for the prophylaxis and treatment of extrapiramidal symptoms caused by neuroleptics. Abuse of anticholinergic agents has been reported in patients with psychotic disorders, on treatment with neuroleptics, and polysubstance use disorders. We are reporting the case of a patient who presented with hypoactive delirium as a consequence of biperiden dependence. The clinician must pay special attention to detect anticholinergic misuse in patients presenting with delirium of unknown cause.