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Behavioural Intervention
iTBS for Psychosis (iSCIP Trial)
Glen Oaks, NY
N/A
Recruiting
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Must not have
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)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 4 weeks
Summary
This trial will examine if stimulating the brain with iTBS can improve social cognitive performance in people with schizophrenia and related disorders. Participants will receive iTBS five days a week for four weeks, with tests, assessments, and scans before and after treatment.
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Who is the study for?
This trial is for individuals aged 18-39 with schizophrenia, schizoaffective disorder, schizophreniform disorder, or unspecified psychosis. They must be on a stable dose of antipsychotics for at least 30 days and able to consent. Exclusions include substance use disorders (except certain cases), intellectual disability, MRI contraindications, pregnancy, type 1 diabetes with complications, unstable medical conditions, neurological diseases affecting movement or seizures.Check my eligibility
What is being tested?
The study tests if iTBS (a form of brain stimulation) applied to the DMPFC can improve social cognition in people with psychotic disorders compared to sham (fake) treatment. Participants will receive daily treatments for four weeks and undergo fMRI scans and cognitive assessments before treatment starts after it ends and six months later.See study design
What are the potential side effects?
While not explicitly stated here, iTBS side effects may include headache or discomfort at the stimulation site; however these are generally mild. The risk profile should be similar to that of standard TMS which is considered safe but requires monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a schizophrenia spectrum disorder.
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I have been on a stable dose of antipsychotic medication for the last 30 days.
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I am between 18 and 39 years old.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have type 1 diabetes diagnosed before I was 35 or have had ketoacidosis.
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I need a strong anxiety medication similar to or more than 2 mg/day of lorazepam.
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I do not have any severe illnesses that could worsen my schizophrenia or make the treatment risky.
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I have a neurological condition like Parkinson's, epilepsy, a history of stroke, or another CNS disorder.
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I have had brain surgery for a psychiatric condition.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in social cognitive performance
Secondary study objectives
Change in social cognitive network functional connectivity
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active iTBSActive Control1 Intervention
Group II: Sham iTBSPlacebo Group1 Intervention
Find a Location
Closest Location:Zucker Hillside Hospital· Glen Oaks, NY· 493 miles
Who is running the clinical trial?
Northwell HealthLead Sponsor
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Wellcome TrustOTHER
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