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New treatment option for Schizophrenia
Official title Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine
ClinicalTrials.gov ID: NCT06003036
What this study is testing
- What it's testing
- In this study, the investigators will examine whether a type of repetitive transcranial magnetic stimulation called accelerated intermittent theta burst stimulation (iTBS) can augment neurocognition in individuals who receive treatment with clozapine. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will undergo a session of iTBS +MRI and session of sham delivery + MRI.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder
- age 18-50 years
- at least 4 months of clozapine treatment
- history of at least 2 failed antipsychotic trials
- competency and willingness to sign informed consent
You likely can't join if
- Serious neurologic or medical condition/treatment that impacts the brain
- a significant risk of suicidal or homicidal behavior
- cognitive or language limitations, or any other factor that would preclude people providing informed consent
- pregnancy or postpartum (\<6 weeks after delivery or miscarriage)
- history of treatment with electroconvulsive therapy
- contraindications for magnetic resonance imaging (e.g., a pacemaker)
See the full eligibility criteria
- A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder
- age 18-50 years
- at least 4 months of clozapine treatment
- history of at least 2 failed antipsychotic trials
- competency and willingness to sign informed consent
- A clinically optimized dosage of clozapine, unchanged for at least 1 month, with a minimum of 150 mg/day
- Serious neurologic or medical condition/treatment that impacts the brain
- a significant risk of suicidal or homicidal behavior
- cognitive or language limitations, or any other factor that would preclude people providing informed consent
- pregnancy or postpartum (\<6 weeks after delivery or miscarriage)
- history of treatment with electroconvulsive therapy
- contraindications for magnetic resonance imaging (e.g., a pacemaker)
- Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-verified moderate or severe substance use disorder, including alcohol use disorder
- seizure disorder or prior history of seizures on clozapine
- patients taking both bupropion and clozapine
- prior issues with intermittent theta burst stimulation/transcranial magnetic stimulation administration Concomitant treatment with serotonin and norepinephrine reuptake inhibitors will be examined on a case-by-case...
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.