Status:
RECRUITING
iTBS to Enhance Social Cognition in People With Psychosis
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Wellcome Trust
Centre for Addiction and Mental Health
Conditions:
Schizophrenia
Schizo Affective Disorder
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief 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 di...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- A history of a DSM-5 substance use disorder (other than cannabis, caffeine, or tobacco) within the past six months; or a positive baseline urine drug screen. Only participants meeting for moderate to severe cannabis use disorder will be excluded.
- Type 1 diabetes mellitus (i.e., insulin-dependent diabetes mellitus with onset \< 35 years of age and/or diabetes mellitus that has been complicated by a prior documented episode of ketoacidosis)
- Acute or unstable medical illness (e.g., delirium, cancer, uncontrolled diabetes, decompensated cardiac, hepatic, renal or pulmonary disease, stroke, or myocardial infarction), whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
- Neurological disease associated with extrapyramidal signs and symptoms (e.g., Parkinson's disease); epilepsy, if the person has had one or more grand mal seizures in the past 18 months; history or physical signs of stroke; any diagnosis of a Central Nervous System (CNS) disorder
- Requires a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher due to the potential of these medications to limit the efficacy of iTBS
- Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history
- Prior Psychosurgery
- Presence of MRI contraindications (e.g., pacemakers)
- Pregnancy
- TMS treatment in the past three months
Key Trial Info
Start Date :
April 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06118268
Start Date
April 18 2023
End Date
April 1 2027
Last Update
May 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004