NCT07060066

Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide an effective repetitive transcranial magnetic stimulation (rTMS) treatment for depressive symptoms in patients with schizophrenia. Schizophrenia patients with depressive symptoms will be exposed to rTMS to improve their symptoms.

Detailed description

Schizophrenia spectrum disorder (SSD) and major depressive disorder (MDD) are often debilitating conditions, and thus not surprising that many SSD patients with comorbid depression have even poorer quality of life, higher suicide risk, worse clinical outcome, and higher rates of re-hospitalization than just having SSD alone. SSD patients with depression (DIS) suffered the unfortunate 'double whammy' by two of the most severe symptom categories in mental health. Transcranial magnetic stimulation (TMS) is a non-invasive means for safely introducing the brain with electrical neural activity through magnetic stimulation on specific locations. Thousands of patients with depression and other psychiatric conditions have benefited from TMS through FDA-approved TMS devices. However, no TMS trial report has directly targeted DIS. The H4 coil is FDA-cleared to be marketed as deep TMS for short-term smoking cessation. This H4 coil targets bilateral insula and prefrontal cortices, which may underlie the depressive symptoms in SSD. The patients with schizophrenia who also have depressive symptoms will receive rTMS via the H4 coil. The efficacy of using H4 rTMS for treating depressive symptoms in schizophrenia patients will be evaluated.

Conditions

• Schizophrenia and Related Disorders

Interventions

Type	Name	Description
DEVICE	Active rTMS stimulation	Active H-coil delivered rTMS sessions will be given three times per treatment visit for up to 20 visits for about 4 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete.
DEVICE	Sham rTMS stimulation	Sham H-coil delivered rTMS sessions will be given three times per treatment visit for up to 20 visits for about 4 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete.

Timeline

• Start date: 2024-05-21
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2025-07-11
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study