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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

change in activation of the working memory network

change in brain functional connectivity within the prefrontal cortex

Secondary outcome measures

explore change in functional magnetic resonance imaging (fMRI) measures versus plasma n-desmethylclozapine/clozapine ratios

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

sham stimulation

2011

Completed Phase 4

~580

transcranial magnetic stimulation

2013

Completed Phase 2

~710

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,679 Total Patients Enrolled

Deepak SarpalLead Sponsor

Deepak K Sarpal, M.D.Principal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

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

Who meets the qualifications to take part in this experiment?

"This trial is looking for 30 individuals, aged 18 to 50, diagnosed with schizophrenia. These participants must have a documented history of antipsychotic treatment failure and at least 4 months experience taking clozapine."

Answered by AI

Does this research incorporate geriatric participation?

"This trial is limited to participants between 18 and 50 years of age. Conversely, there are 93 clinical trials for those below the legal minimum and 239 designed specifically for elderly patients."

Answered by AI

Is enrollment still accessible to volunteers for this study?

"Clinicaltrials.gov shows that this medical trial, which was initially posted on September 1st 2023 and last updated on August 25th 2023, is no longer recruiting patients. Yet there are 471 other trials actively seeking participants at the time of writing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine

Deepak Sarpal 2023. "Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003036.

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