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iTBS to Enhance Social Cognition in People With Psychosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 39 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether iTBS, a type of magnetic brain stimulation, helps people understand social cues better than sham (inactive) treatment. It is for adults ages 18–39 with schizophrenia or certain related disorders. Treatment takes place 5 days a week for 4 weeks, with brain scans and tests before, after, and 6 months later.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–39 years old.
  • A study interview confirms schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified.
  • You have been prescribed antipsychotic medicine for at least 60 days, with no dose change for 30 days before joining.
  • You can understand the study and freely agree to take part.

Who can't join

  • You had a substance use disorder in the past 6 months, or a positive urine drug test at the start. Caffeine and tobacco use disorders are allowed. Cannabis use disorder excludes you only if moderate or severe.
  • You have type 1 diabetes.
  • You have a new or unstable illness that could affect your mental health care or make study treatment less safe.
  • You have a brain or spinal cord disorder, signs or a history of stroke, or past surgery to treat a mental illness. For epilepsy, you are excluded if you had a major convulsive seizure in the past 18 months.
  • You need a benzodiazepine medicine at a daily dose equal to 2 mg of lorazepam or more, or you had TMS (magnetic brain stimulation) in the past 3 months.
  • The study interview and your history suggest an intellectual disability, which affects learning and daily life skills.
  • You cannot safely have an MRI scan, for example because you have a pacemaker.
  • You are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NY