iTBS to Enhance Social Cognition in People With Psychosis

Launched by NORTHWELL HEALTH · Nov 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called iTBS, which stands for intermittent theta burst stimulation, to see if it can help improve social skills in people diagnosed with conditions like schizophrenia or schizoaffective disorder. The main goals are to compare how well participants do socially after receiving either the active iTBS treatment or a placebo (sham treatment). Participants will receive treatment five days a week for four weeks, and their progress will be checked using brain scans and cognitive tests before, right after, and six months after the treatment.

To be eligible for this study, participants must be between 18 and 39 years old and have a diagnosis of one of the specified mental health conditions. They also need to have been on a stable dose of antipsychotic medication for at least 30 days before starting the trial. Throughout the study, participants will undergo assessments and brain scans to track any changes in their social skills and brain activity. This trial is currently recruiting, and it's open to all genders.

Gender

ALL

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