Recruiting

rTMS

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07060066

Conditions

Schizophrenia and Related Disorders

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Active rTMS stimulation

Sham rTMS stimulation

Study Details

Brief 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.

Conditions

Schizophrenia and Related Disorders

Study ID

NCT07060066

Start date

Oct 23, 2025

Status verified date

Aug, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active rTMS stimulation

Participants will receive active H-coil delivered rTMS in each treatment visit for up to 20 treatment visits for about 4 weeks. In each visit, there are three rTMS sessions with inter-rTMS-session interval of about 30 minutes.

sham comparator: Sham rTMS stimulation

Participants will receive sham H-coil delivered rTMS in each treatment visit for up to 20 treatment visits for about 4 weeks. In each visit, there are three rTMS sessions with inter-rTMS-session interval of about 30 minutes.

Interventions

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.

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 outcome measure

  • Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI) [ Time Frame: baseline, visit 11 (about 2 week after baseline), visit 21 (about 4 weeks after baseline) ]

Central Contacts and Locations

Central contacts

Alina Siatka

713-486-2740Alina.Siatka@uth.tmc.edu

Xiaoming Du, PhD

443-882-9717Xiaoming.Du@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Xiaoming Du, PhD

713-486-2700Xiaoming.Du@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • transcranial magnetic stimulation
  • schizophrenia
  • depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-08-05.