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iTBS to Enhance Social Cognition in People With Psychosis

Study acronym: iSCIP
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date pushed from Apr 18, 2023 to Oct 30, 2023
  2. Eligibility criteria expanded, about 14 words Publications: details revised at 1 of 1 entry Show 1 more changeShow less
    • Publications: details revised at 1 of 1 entry
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06118268
Lead Sponsor Northwell Health
Collaborators: Wellcome Trust, Centre for Addiction and Mental Health, University of Maryland, Baltimore
Conditions Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders, Psychosis Nos/Other
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov