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Cholinesterase Inhibitor

Rivastigmine + Scopolamine for Auditory Hallucinations

Phase < 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during fmri scans / task completion which will take approximately 90 minutes
Awards & highlights

Study Summary

This trial uses computational modeling to find new ways to treat auditory hallucinations, which are a symptom of psychotic illness.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of conditioned hallucinations exhibited during saline vs placebo administration
Secondary outcome measures
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 Capsule
2017
Completed Phase 4
~1960

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,092 Total Patients Enrolled
46 Trials studying Psychosis
10,684 Patients Enrolled for Psychosis
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,783 Total Patients Enrolled
6 Trials studying Psychosis
3,021 Patients Enrolled for Psychosis

Media Library

Rivastigmine Capsule (Cholinesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04366518 — Phase < 1
Psychosis Research Study Groups: Aim 1: Healthy Controls, Aim 2: Those with psychosis/hallucinations
Psychosis Clinical Trial 2023: Rivastigmine Capsule Highlights & Side Effects. Trial Name: NCT04366518 — Phase < 1
Rivastigmine Capsule (Cholinesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04366518 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over the age of 18 able to partake in this research project?

"The study necessitates that suitable candidates are between 18 and 65 years old. For those younger than 18 or older than 65, there are 32 studies and 49 studies respectively to consider."

Answered by AI

Is enrollment into this trial still open to the public?

"Confirmed. The information found on clinicaltrials.gov demonstrates that this research is still recruiting participants, with the trial first being posted in July 15th 2021 and having been updated recently on March 2nd 2022. 35 people are required across 1 medical site for proper completion of the study."

Answered by AI

How many individuals have been approved to participate in this research?

"Affirmative, clinicaltrials.gov shows that this trial is actively enrolling participants. This research project was first posted on July 15th 2021 and the latest update occurred March 2nd 2022. 35 volunteers are being sought out from a single medical centre."

Answered by AI

Who is qualified to take part in this research endeavor?

"To be eligible to participate in this medical trial, potential participants must have a diagnosis of psychosis and lie between the ages of 18 and 65. The study is enrolling 35 patients in total."

Answered by AI

What condition is Rivastigmine Transdermal Product most commonly employed to alleviate?

"Rivastigmine Transdermal Product is often prescribed to those with Parkinson's disease, though its efficacy against nausea, Alzheimer's and airsickness has also been documented."

Answered by AI

Have any other trials showcased the efficacy of Rivastigmine Transdermal Product?

"Currently, 11 clinical trials analyzing Rivastigmine Transdermal Product are ongoing with 3 of them in Phase 3. Notably, 62 distinct locations have studies for this drug open and many are found near Bangalore, Karnataka."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Toward a Computationally-Informed, Personalized Treatment for Hallucinations
2021. "Toward a Computationally-Informed, Personalized Treatment for Hallucinations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04366518.
~9 spots leftby Apr 2025
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