Actively Recruiting
Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia
Led by The University of Texas Health Science Center, Houston · Updated on 2025-12-17
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate repetitive transcranial magnetic stimulation (rTMS) treatment for depressive symptoms in patients with schizophrenia spectrum disorder (SSD). Patients with both schizophrenia and depression often experience poorer quality of life, higher suicide risk, and worse clinical outcomes compared to those with schizophrenia alone. The study focuses on using a special H4 coil, which is FDA-cleared for deep TMS, targeting brain areas linked to depression in SSD patients. Participants will be randomly assigned to receive either active or sham rTMS treatment using the H4 coil. Treatments involve up to 20 visits over about 4 weeks, with three rTMS sessions per visit separated by 30-minute breaks. Each session lasts about 3 to 4 minutes. The trial compares the effects of actual magnetic stimulation with a sham procedure to assess its impact on depressive symptoms. During the study, participants will undergo brain scans including functional MRI at baseline, two weeks, and four weeks to measure brain connectivity. They will also have electroencephalography (EEG) tests to assess brain responses and complete depression rating scales. Researchers will monitor safety and treatment effects throughout the visits. The trial includes adults aged 18 to 60 years and continues until June 2030.
CONDITIONS
Brief Title
Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female between 18 and 60 years old
- Able to provide written informed consent
- Diagnosed with schizophrenia-spectrum disorder
- Calgary depression scale for schizophrenia score of 3 or higher
You will not qualify if you...
- Unable to provide informed consent
- Major medical illnesses affecting brain function, such as stroke, seizures, significant head trauma, CNS infection, brain tumor, or other neurological conditions
- Significant alcohol or drug use other than nicotine or marijuana dependence
- Unable to avoid alcohol or marijuana for 24 hours before experiments
- Pregnancy or potential pregnancy without contraceptive use
- Inability to undergo MRI due to metal implants or refusal to enter MRI scanner
- Failed TMS safety questionnaire
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 4 weeks
Participants receive three rTMS sessions per treatment visit using the H4 coil targeting bilateral prefrontal and insular regions to treat depressive symptoms in schizophrenia.
Up to 20 treatment visits
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Alina Siatka
X
Xiaoming Du, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here