Recruiting
Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia
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.
ClinicalTrials.gov IDNCT07060066
PhaseNA
Enrollment120
SponsorThe University of Texas Health Science Center, Houston
Age18 Years
SexALL
Conditions studied
Schizophrenia and Related Disorders
About this study
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.
Interventions
- 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.
Primary outcomes
- Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI) (baseline, visit 11 (about 2 week after baseline), visit 21 (about 4 weeks after baseline))
Eligibility information
Inclusion Criteria:
* Male and female ages between ages 18-60 years.
* Ability to give written informed consent (age 18 or above).
* Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.
* Score of Calgary depression scale for schizophrenia (CDSS) ≥ 3.
Exclusion Criteria:
* Inability to sign informed consent.
* Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but are not limited to: stroke, repeated seizure, history of significant head trauma with cognitive sequela, CNS infection or tumor, other significant brain neurological conditions.
* Significant alcohol or other drug use other than nicotine or marijuana dependence.
* Inability to refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
* Pregnancy, as classified by a woman of child-bearing potential who is not using a contraceptive and has missed a menstrual period; or by self-report; or by positive urine pregnancy test.
* For MRI, inability to participate in the MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or declining to get in the scanner.
* Failed TMS safety questionnaire.
Study locations
- The University of Texas Health Science Center at Houston, Houston, Texas 77030 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.