iTBS to Enhance Social Cognition in People With Psychosis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to examine if iTBS applied to the DMPFC improves social cognitive performance compared to sham stimulation in people diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified. The main objectives of this trial are: * Compare changes in social cognitive performance between the active vs. sham treatment groups * Compare changes in social cognitive network functional connectivity between the active vs. sham treatment groups Each participant will receive iTBS (active or sham) five days per week for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at pre-treatment, post-treatment, and 6 months after the completion of treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 39
Healthy Volunteers: f
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• Age 18-39 years.

• DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified (documented by SCID-5).

• Prescription of antipsychotic medication for at least 60 days and constant dose for 30 days prior to study entry (either first- or second-generation antipsychotics permitted).

• Able to participate in the informed consent process and provide voluntary informed consent.

Locations
United States
New York
Zucker Hillside Hospital
RECRUITING
Glen Oaks
Contact Information
Primary
Andrea Joanlanne
ajoanlanne@northwell.edu
718-470-8898
Time Frame
Start Date: 2023-04-18
Estimated Completion Date: 2027-04
Participants
Target number of participants: 100
Treatments
Active_comparator: Active iTBS
Sham_comparator: Sham iTBS
Related Therapeutic Areas
Sponsors
Collaborators: University of Maryland, Baltimore, Wellcome Trust, Centre for Addiction and Mental Health
Leads: Northwell Health

This content was sourced from clinicaltrials.gov