Clinical trial NCT06118268: iTBS to Enhance Social Cognition in People With Psychosis
Official title: iTBS to Enhance Social Cognition in People With Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Schizophreniform Disorders
Psychosis Nos/Other
Keywords: TMS
iTBS
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: Centre for Addiction and Mental Health
name: University of Maryland, Baltimore
First posted: 2023-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Change in social cognitive performance
timeFrame: From baseline to 4 weeks
measure: Change in social cognitive performance
timeFrame: From baseline to 4 weeks
measure: Change in social cognitive performance
timeFrame: From baseline to 4 weeks
Secondary outcomes:
measure: Change in social cognitive network functional connectivity
timeFrame: From baseline to 4 weeks
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: Zucker Hillside Hospital
state: New York
Study officials:
References: