NCT06118268 iTBS to Enhance Social Cognition in People With Psychosis
| NCT ID | NCT06118268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-10-30 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: 1. Age 18-39 years. 2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified (documented by SCID-5). 3. 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). 4. Able to participate in the informed consent process and provide voluntary informed consent. Exclusion Criteria: 1. 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. 2. 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) 3. 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 4. 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 5. 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 6. Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history 7. Prior Psychosurgery 8. Presence of MRI contraindications (e.g., pacemakers) 9. Pregnancy 10. TMS treatment in the past three months
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06118268 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 39 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06118268 currently recruiting?
Yes, NCT06118268 is actively recruiting participants. Contact the research team at ajoanlanne@northwell.edu for enrollment information.
Where is the NCT06118268 trial being conducted?
This trial is being conducted at Glen Oaks, United States.
Who is sponsoring the NCT06118268 clinical trial?
NCT06118268 is sponsored by Northwell Health. The trial plans to enroll 100 participants.
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