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Behavioural Intervention

iTBS for Psychosis (iSCIP Trial)

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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 4 weeks
Awards & highlights

iSCIP Trial 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.

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.

iSCIP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

iSCIP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in social cognitive performance
Secondary outcome measures
Change in social cognitive network functional connectivity

iSCIP Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active iTBSActive Control1 Intervention
Group II: Sham iTBSPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreOTHER
688 Previous Clinical Trials
374,556 Total Patients Enrolled
Northwell HealthLead Sponsor
460 Previous Clinical Trials
470,943 Total Patients Enrolled
Centre for Addiction and Mental HealthOTHER
356 Previous Clinical Trials
81,358 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could individuals aged eighty or under take part in this research program?

"This medical trial is seeking participants of legal age (18+) and have not yet reached the milestone of 39 years old."

Answered by AI

Is there an ongoing recruitment process for this medical experiment?

"Affirmative. According to clinicaltrials.gov, this medical study was initially posted on April 18th 2023 and is actively recruiting for participants now. The trial needs 100 volunteers from a single location."

Answered by AI

How many individuals are currently partaking in this medical experiment?

"Affirmative. Data posted on clinicaltrials.gov affirms that this medical study, which was first advertised on April 18th 2023, is actively in pursuit of participants. Approximately 100 individuals must be enrolled from a single trial site location."

Answered by AI

For whom is this research program appropriate?

"Recruitment for this medical trial is ongoing, with 100 participants sought after. Qualification criteria states that patients must suffer from schizophrenia and be between 18-39 years of age in order to join the study."

Answered by AI

Who else is applying?

What site did they apply to?
Zucker Hillside Hospital
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I've tried many medication that didn't work. I really really want to be better and function in society.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
iTBS to Enhance Social Cognition in People With Psychosis
Anil K. Malhotra 2023. "iTBS to Enhance Social Cognition in People With Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118268.
~67 spots leftby Apr 2027
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