Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorDeepak K. Sarpal, M.D.
About this trial
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. The order for these sessions will be blinded and randomized. The investigators predict that accelerated iTBS will enhance neurocognition relative to sham delivery.
Eligibility criteria
Qualifiers
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
Disqualifiers
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 subjects providing informed consent
pregnancy or postpartum (<6 weeks after delivery or miscarriage)
Trial design
Treatments tested in this trial
- sham stimulation
- transcranial magnetic stimulation
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Deepak K. Sarpal, M.D.
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov