What side effects are associated with this type of intervention?

Common treatments for psychosis include antipsychotic medications and neuromodulation techniques. Typical antipsychotics can cause extrapyramidal symptoms such as tremors and tardive dyskinesia, while atypical antipsychotics may lead to weight gain, metabolic syndrome, and increased mortality in older adults with dementia. Neuromodulation techniques like Electroconvulsive Therapy (ECT) can result in memory impairment and headaches, whereas Transcranial Magnetic Stimulation (TMS) has shown mixed results, with some studies indicating minimal side effects and others suggesting potential cognitive impacts.

What prior FDA approvals exist?

The FDA has approved several second-generation antipsychotics for the treatment of psychosis, including aripiprazole, brexpiprazole, quetiapine, risperidone, cariprazine, ziprasidone, and olanzapine. These medications are commonly used to treat schizophrenia and bipolar disorder, targeting symptoms such as hallucinations and delusions. Aripiprazole and brexpiprazole are often preferred due to their relatively favorable side effect profiles. Additionally, newer treatments like lumateperone have been approved for schizophrenia, offering another option for patients with treatment-resistant forms of the disorder. These drugs work by modulating neurotransmitter activity in the brain, which is crucial for managing psychotic symptoms.

What other types of research exist?

Promising, novel alternatives to pharmacological agents for psychosis patients in 2024 include transcranial magnetic stimulation (TMS), transcranial direct-current stimulation (tDCS), and cranial electrotherapy stimulation (CES). These neuromodulation techniques offer potential benefits by directly modulating brain activity.

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Cholinesterase Inhibitor

Rivastigmine + Scopolamine for Auditory Hallucinations

Q: What is the mechanism of action of this treatment?

Common treatments for psychosis primarily involve antipsychotic medications, which work by modulating neurotransmitter activity, especially dopamine and serotonin pathways, to reduce symptoms like hallucinations and delusions. This is crucial for psychosis patients as it helps manage their symptoms and improve their quality of life. Emerging research, such as computational modeling and pharmacological manipulation of brain activity parameters, aims to personalize treatment, potentially leading to more effective and tailored therapeutic strategies.

Phase < 1

Recruiting

Led By Albert Powers, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with schizophrenia schizoaffective, schizophreniform, schizotypal, or brief psychotic disorder

English speaking

Must not have

Any neurological, medical or developmental problem that is known to impair cognition significantly

History of urinary retention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during fmri scans / task completion which will take approximately 90 minutes

Summary

This trial tests two drugs, scopolamine and rivastigmine, on people who hear voices and don't respond to usual treatments. Scopolamine may increase these experiences by affecting how the brain processes information, while rivastigmine may reduce them by improving this process. Rivastigmine has been shown to help with memory and behavior in patients with certain brain disorders. The goal is to find better treatments for these patients.

Who is the study for?

This trial is for English-speaking adults aged 18-65 with a diagnosis of schizophrenia or related disorders, who experience weekly auditory hallucinations. They must be right-handed and not have metal implants, pacemakers, or severe claustrophobia that would prevent MRI scans. Pregnant individuals, those using certain medications, or with a history of substance dependence, significant cognitive impairments, seizures, violence, or specific medical conditions are excluded.

What is being tested?

The study tests if Rivastigmine (a capsule), Scopolamine (a patch), and placebo versions can influence the occurrence of auditory hallucinations in psychosis. It's based on computational models linking brain activity to these symptoms and aims at personalized treatment by pharmacologically altering brain processes involved in hallucinations.

What are the potential side effects?

Rivastigmine may cause nausea, vomiting, weight loss; Scopolamine might lead to dry mouth, blurred vision and dizziness. Placebos typically have no active ingredients but can still result in side effects due to the body's expectation of drug effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a schizophrenia spectrum disorder.

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I speak English.

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I am between 18 and 65 years old.

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I hear voices at least once a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that greatly affects my thinking or memory.

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I have had issues with not being able to empty my bladder fully.

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I have a history of seizures.

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I am currently taking medication that affects my nervous system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during fmri scans / task completion which will take approximately 90 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during fmri scans / task completion which will take approximately 90 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and during fmri scans / task completion which will take approximately 90 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of conditioned hallucinations exhibited during saline vs placebo administration

Secondary study objectives

Functional correlation with model belief trajectories

Prior-Weighting Parameter of the Hierarchical Gaussian Filter

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Aim 2: Those with psychosis/hallucinationsExperimental Treatment2 Interventions

Participants who have a psychosis spectrum diagnosis and frequent auditory hallucinations will be given Rivastigmine capsule versus placebo capsule.

Group II: Aim 1: Healthy ControlsPlacebo Group2 Interventions

Healthy controls will be given scopolamine patches versus placebo patch.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo Patch

2011

Completed Phase 4

~4500

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for psychosis primarily involve antipsychotic medications, which work by modulating neurotransmitter activity, especially dopamine and serotonin pathways, to reduce symptoms like hallucinations and delusions. This is crucial for psychosis patients as it helps manage their symptoms and improve their quality of life. Emerging research, such as computational modeling and pharmacological manipulation of brain activity parameters, aims to personalize treatment, potentially leading to more effective and tailored therapeutic strategies.