Status:
COMPLETED
Auditory Control Enhancement (ACE) in Schizophrenia
Lead Sponsor:
Brian A Coffman, PhD
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Auditory Hallucinations
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to investigate neural markers of target engagement to further develop auditory control enhancement (ACE) as a novel, inexpensive, and noninvasive intervention to ...
Detailed Description
Auditory hallucinations associated with schizophrenia (Sz) are pervasive, debilitating, and disturbing. Unfortunately, they are also difficult to treat - auditory hallucinations persist in about 25% o...
Eligibility Criteria
Inclusion
- Between the ages of 18-40
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Psychosis not otherwise specified (NOS), Affective Psychosis with mood incongruent hallucinations.
- ability to provide informed consent
- Intelligence quotient (IQ) \>= 70, as measured by the Weschler Abbreviated Scale of Intelligence (WASI)
- \<5 years since the onset of first psychotic episode
- persistent auditory hallucinations without remission despite attempting \>2 antipsychotic medications and having \> 1 month of medication compliance
Exclusion
- hearing deficit as assessed by audiometry (hearing threshold \> 30 decibels (dB) nHL)
- standard MRI contraindications (e.g. cardiac pacemaker, aneurysm clip, cochlear implants, history of metal fragments in body, neurostimulators, weight of 300 lbs. or more, or claustrophobia)
- \[self report\] head injury with loss of conscious \> 10 min, medical illness affecting brain function or structure, significant neurologic disorder (e.g. seizure disorder),
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) substance use disorder - other than cannabis - and except individuals who have met at least early remission criteria (3 months without dependence symptoms) or a psychotic illness with a temporal relation to a substance use disorder
- currently pregnant or early postpartum (\<6 weeks after delivery or miscarriage)
- currently taking medications that affect alertness, other than antipsychotic medication (e.g. sedatives, tranquilizers, muscle relaxants, and sleeping aids)
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06155695
Start Date
September 5 2023
End Date
December 18 2024
Last Update
February 14 2025
Active Locations (1)
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1
Western Psychiatric Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213