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Accelerated Transcranial Magnetic Stimulation for Schizophrenia

N/A
Recruiting
Led By Deepak K Sarpal, M.D.
Research Sponsored by Deepak Sarpal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a type of magnetic stimulation can improve thinking in people who take clozapine. Participants will get two magnetic sessions, one real and one fake, to compare the effects.

Who is the study for?
This trial is for individuals aged 18-50 with schizophrenia or schizoaffective disorder, who have tried at least two antipsychotic treatments without success and are on a stable dose of clozapine. It's not suitable for those with cognitive impairments, recent pregnancy, MRI contraindications like pacemakers, previous negative reactions to TMS, serious brain-affecting conditions, high suicide risk, severe substance use disorders or seizures.
What is being tested?
The study tests if accelerated intermittent theta burst stimulation (iTBS), a type of transcranial magnetic stimulation (TMS), can improve thinking abilities in people taking clozapine. Participants will receive iTBS and sham (fake) treatment in random order while blinded to the type they're getting; both sessions include an MRI scan.
What are the potential side effects?
While the document doesn't list specific side effects of iTBS or sham stimulation directly related to this trial, common side effects from TMS may include headache, scalp discomfort during treatment sessions and rare risk of seizure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in activation of the working memory network
change in brain functional connectivity within the prefrontal cortex
Secondary study objectives
explore change in functional magnetic resonance imaging (fMRI) measures versus plasma n-desmethylclozapine/clozapine ratios

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: iTBS, then ShamExperimental Treatment2 Interventions
Group II: Sham, then iTBSExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial magnetic stimulation
2013
Completed Phase 2
~760
sham stimulation
2011
Completed Phase 4
~580

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,914 Previous Clinical Trials
2,738,545 Total Patients Enrolled
Deepak SarpalLead Sponsor
Deepak K Sarpal, M.D.Principal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
105 Total Patients Enrolled
~10 spots leftby Jun 2025
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