NCT04366518 Toward a Computationally-Informed, Personalized Treatment for Hallucinations
| NCT ID | NCT04366518 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Yale University |
| Condition | Hallucinations, Auditory |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2021-07-15 |
| Primary Completion | 2032-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 35 participants in total. It began in 2021-07-15 with a primary completion date of 2032-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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)
Contact & Investigator
Albert Powers, MD, PhD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT04366518 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hallucinations, Auditory. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04366518 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04366518 currently recruiting?
Yes, NCT04366518 is actively recruiting participants. Contact the research team at albert.powers@yale.edu for enrollment information.
Where is the NCT04366518 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT04366518 clinical trial?
NCT04366518 is sponsored by Yale University. The principal investigator is Albert Powers, MD, PhD at Yale University. The trial plans to enroll 35 participants.