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New treatment option for Hallucinations, Auditory
Official title Toward a Computationally-Informed, Personalized Treatment for Hallucinations
ClinicalTrials.gov ID: NCT04366518
What this study is testing
What is Rivastigmine Transdermal System?
Rivastigmine Transdermal System is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hallucinations, auditory.
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
- Auditory hallucinations are among the most distressing aspects of psychotic illness, and between 10 and 30% of people with hallucinations do not respond to antipsychotic medications. The authors have used computational modeling of behavior to link brain activity to development of auditory hallucinations in the hope of guiding new treatment development.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age 18-65
- English speaking
- Right handedness
- Diagnosed with schizophrenia schizoaffective, schizophreniform, schizotypal, or brief psychotic disorder
- History of auditory verbal hallucinations occurring at least weekly
You likely can't join if
- Current substance dependence or active use as determined by drug test.
- Any neurological, medical or developmental problem that is known to impair cognition significantly
- Contraindications for MR scanning including metallic implants of any kind, pacemakers and history of accidents with metal, claustrophobia
- History of seizures
- History of violence
- History of suicide
See the full eligibility criteria
- Age 18-65
- English speaking
- Right handedness
- Diagnosed with schizophrenia schizoaffective, schizophreniform, schizotypal, or brief psychotic disorder
- History of auditory verbal hallucinations occurring at least weekly
- Current substance dependence or active use as determined by drug test.
- Any neurological, medical or developmental problem that is known to impair cognition significantly
- Contraindications for MR scanning including metallic implants of any kind, pacemakers and history of accidents with metal, claustrophobia
- History of seizures
- History of violence
- History of suicide
- Pregnancy (determined by urine pregnancy test)
- Concurrent participation in any other intervention study
- History of urinary retention
- History of delirium
- Current use of any cholinergic or anticholinergic medication
- History of asthma, diabetes, and cardiovascular disease
- Evidence of cardiovascular disease on EKG
- Individuals who have been on dopamine-2 antagonists for less than 6 months (to limit risk of EPS)
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, 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 - 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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.