Toward a Computationally-Informed, Personalized Treatment for Hallucinations
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|ClinicalTrials.gov Identifier: NCT04366518|
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : March 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hallucinations, Auditory Psychosis||Drug: Rivastigmine Transdermal Product Drug: Scopolamine Drug: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Rivastigmine vs Placebo|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Toward a Computationally-Informed, Personalized Treatment for Hallucinations|
|Actual Study Start Date :||July 15, 2021|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2024|
Experimental: Aim 2: Those with psychosis/hallucinations
Participants who have a psychosis spectrum diagnosis and frequent auditory hallucinations will be given Rivastigmine patch versus placebo patch
Drug: Rivastigmine Transdermal Product
Consistent with safety and efficacy demonstrated in prior studies, the authors propose two three-hour treatments with a transdermal rivastigmine patch vs. placebo separated by a 16-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 patch and a visit for the second patch. This will be a blinded study and no study team member except for the unblinded team member will know which patch 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
Participants in Aim 2 will receive a placebo patch versus rivastigmine patch
Placebo Comparator: Aim 1: Healthy Controls
Healthy controls will be given scopolamine patches versus placebo patch.
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.
Participants in Aim 1 will receive a placebo patch versus scopolamine patch.
- Number of conditioned hallucinations exhibited during saline vs placebo administration [ Time Frame: During fMRI scans / task completion which will take approximately 90 minutes ]Participants will perform the Conditioned Hallucinations task while in the scanner; the authors hypothesize that number of conditioned hallucinations exhibited during the task will be higher under placebo than physostigmine, but only in those who have high prior weighting on baseline assessment.
- Prior-Weighting Parameter of the Hierarchical Gaussian Filter [ Time Frame: During fMRI scans / task completion which will take approximately 90 minutes ]Behavioral responses will be used to fit a parameter of the Hierarchical Gaussian Filter model corresponding to the ratio of precision of priors to precision of incoming sensory evidence.
- Functional correlation with model belief trajectories [ Time Frame: During fMRI scans / task completion which will take approximately 90 minutes ]Behavioral responses will be used to fit belief trajectories across the course of the experiment, and whole-brain analyses will measure correlation of brain activity with these computed trajectories.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366518
|Contact: Albert Powers, MD, PhDemail@example.com|
|Contact: Brittany Quaganfirstname.lastname@example.org|
|United States, Connecticut|
|Connecticut Mental Health Center||Recruiting|
|New Haven, Connecticut, United States, 06519|
|Contact: Albert Powers, M.D., Ph.D|