Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2024
CompletedFirst Submitted
Initial submission to the registry
July 1, 2025
CompletedFirst Posted
Study publicly available on registry
July 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
December 17, 2025
December 1, 2025
6 years
July 1, 2025
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI)
rsFC values will be reported as a Z-score with a range of -1 to 1, with greater absolute values indicating stronger brain connectivity.
baseline, visit 11 (about 2 week after baseline), visit 21 (about 4 weeks after baseline)
Secondary Outcomes (3)
Electrophysiological response as indicated by mismatch negativity as assessed by electroencephalography (EEG)
baseline, visit 11 (about 2 week after baseline), visit 21 (about 4 weeks after baseline)
Electrophysiological response as indicated by steady-state auditory evoked responses from electroencephalography recording (EEG)
baseline, visit 11 (about 2 week after baseline), visit 21 (about 4 weeks after baseline)
Depression as assessed by the Calgary Depression Scale
baseline, visit 11 (about 2 week after baseline), visit 21(about 4 weeks after baseline)
Study Arms (2)
Active rTMS stimulation
ACTIVE COMPARATORParticipants 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 rTMS stimulation
SHAM COMPARATORParticipants 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 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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoming Du, PhD
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 1, 2025
First Posted
July 11, 2025
Study Start
May 21, 2024
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2030
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share