Bilateral prefrontal and insular TMS to treat depression in schizophrenia.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with schizophrenia and depressive symptoms will receive either active or sham rTMS delivered with an H4 coil that targets bilateral insula and prefrontal cortices. Treatment sessions are delivered in person at the study site and depressive symptoms are measured with the Calgary Depression Scale for Schizophrenia (CDSS). Eligible participants are ages 18–60, able to give informed consent, and have a CDSS score of 3 or higher. Major neurological illness, active problematic substance use, pregnancy, or inability to consent are exclusion criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Xiaoming Du, PhD — The University of Texas Health Science Center, Houston
• Study coordinator: Alina Siatka
• Email: Alina.Siatka@uth.tmc.edu
• Phone: 713-486-2740

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.