Restoring Spindle and Thalamocortical Efficiency in Early-Course Schizophrenia Patients Using Auditory Stimulation

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Schizophrenia

In brief

The purpose of this research is to identify differences in brain activity during sleep between health individuals and individuals with schizophrenia, schizophreniform, or schizoaffective disorder. This study will also investigate whether tones played during deep sleep can enhance specific features of sleep and whether enhancing such features is related to an improvement in cognitive performance.

Key facts

Study ID

NCT05956951

Run by

Fabio Ferrarelli

People needed

200

Starts

2023-07-20

Expected to finish

2028-06-01

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Early-course schizophrenia (EC-SCZ):
• ages 18-40 years
• current DSM-IV defined diagnosis of schizophrenia, schizophreniform or schizoaffective disorder, not drug-induced, with no previously reported psychotic episode
• duration of ≤5 years from beginning of psychosis, defined by report of symptoms and/or history of treatment according to clinical guidelines employed in our University of Pittsburgh Medical Center (UPMC) psychoses clinics in Pittsburgh
• lifetime exposure to antipsychotic medications ≤5 years
• Healthy controls (HC):
• ages 18-40 years
• no lifetime history of psychiatric disorders
• no first-degree family history of schizophrenia spectrum disorder or mood disorder with psychotic features.

You may not qualify if…

• General exclusion criteria:
• DSM-IV intellectual disability
• significant head injury
• medical illness affecting brain function or structure
• pregnancy or postpartum (<6 weeks after delivery or miscarriage)
• significant neurological disorder (e.g. seizure disorder)
• inability to provide informed consent
• current or past co-morbidity for alcohol or psychoactive substance dependence
• substance abuse other than cannabis and/or alcohol within the past one year
• For EC-SCZ:
• a) a psychotic illness with a temporal relation to substance use or head injury
• For healthy controls (HC):
• difficult falling and/or staying asleep for more than half the nights of a week, on average
• diagnosis of sleep apnea or restless leg syndrome
• sleeping less than 5 hours or more than 10 hours daily, on average

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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