Toward a Computationally-Informed, Personalized Treatment for Hallucinations

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04366518
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Hallucinations, Auditory
  • Psychosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rivastigmine Transdermal System — DRUG
    Rivastigmine doses will be administered transdermally using 9.5 mg/24 hr transdermal patches. Participants will be randomized to two treatments with oral rivastigmine vs. placebo separated by a 15-hour washout period (\>5 half-lives to eliminate any residual effects). This will require three separate visits: a baseline visit, a visit for the first transdermal treatment and a visit for the second transdermal treatment. All visits include fMRI scans. The first transdermal patch will be administered 8-14 hours before the scan. After the washout period, the second transdermal patch will be administered 8-14 hours before the scan. No study team member except for the unblinded team member will know which capsule the participant receives first. Because we are interested in rivastigmine as a probe for a pre-identified computational/physiological abnormality, we will median-split groups post-hoc for the purposes of analysis.
  • Scopolamine — DRUG
    The authors have chosen to use scopolamine to determine the effects of cholinergic antagonism, as treatment with scopolamine demonstrates a dose-related increase in propensity toward conditioned hallucinations and in doses much higher than those proposed here, can cause spontaneous hallucinations. At the proposed dose, scopolamine has an excellent safety profile and has been used routinely for nearly 20 years for treatment of nausea due to surgery or motion sickness in adults and children. Scopolamine is available in the US only as a 1mg / 72 hours transdermal patch, and peak plasma levels are reached within 24 hours. This standard dosage level is very well tolerated in the general population.
  • Placebo Patch — DRUG
    Participants in Aim 2 will receive a placebo patch versus rivastigmine patch.
  • Placebo Patch — DRUG
    Participants in Aim 1 will receive a placebo patch versus scopolamine patch.

Study Details

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. The proposed studies take the first step toward individualized treatment approaches to hallucinations by attempting causal, pharmacological manipulation of relevant model parameters underlying these phenomena.

Key Dates

Start date
Jul 15, 2021
Status verified
Jun 2025
Primary completion
Aug 31, 2032
Completion
Aug 31, 2032

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Aim 2: Those with psychosis/hallucinations
    Participants who have a psychosis spectrum diagnosis and frequent auditory hallucinations will be given Rivastigmine capsule versus placebo capsule.
  • Placebo Comparator: Aim 1: Healthy Controls
    Healthy controls will be given scopolamine patches versus placebo patch.

Primary Outcome Measure

Number of conditioned hallucinations exhibited during saline vs placebo administration [ Time Frame: During fMRI scans / task completion which will take approximately 90 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Mental Health CenterNew HavenConnecticut06519
Albert Powers, M.D., Ph.D

Find similar trials in New Haven, CT

By research site
Connecticut Mental Health Center· New Haven, CT

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