Schizophrenia and Related DisordersNCT07060066
Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia
A study testing Active rTMS stimulation in people with Schizophrenia and Related Disorders, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia and Related Disorders
- What is being tested?
- Active rTMS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Xiaoming Du, PhD, 713-486-2700, Xiaoming.Du@uth.tmc.edu
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.
Read the 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
- Being tested
- Active rTMS stimulation, Sham rTMS stimulation
- Keywords
- transcranial magnetic stimulation, schizophrenia, depression
- Medical subject headings
- Schizophrenia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMS stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS stimulation | Active comparator | 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. Receives: Device: Active rTMS stimulation |
| Sham rTMS stimulation | Sham comparator | 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. Receives: Device: Sham rTMS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Mismatch negativity values will be reported in microvolts (uV). Mismatch negativity is measured by subtracting the averaged response to a set of standard stimuli from the average response to deviant stimuli, and taking the amplitude of this difference in a given timepoint.
Measured: 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)
Steady-state auditory evoked responses will be reported. The responses are measured by calculating the ratio of the power at target frequency over power at the surrounding background frequencies. The ration will be obtained in a given timepoint.
Measured: baseline, visit 11 (about 2 week after baseline), visit 21 (about 4 weeks after baseline)
Depression as assessed by the Calgary Depression Scale
Total score of the Calgary Depression Scale will be reported and ranges from 0 to 27, with a higher score indicating greater depression.
Measured: baseline, visit 11 (about 2 week after baseline), visit 21(about 4 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start23 Oct 2025
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Xiaoming Du, The University of Texas Health Science Center, Houston
- Investigators
- Xiaoming Du, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060066
- Sponsor's protocol ID
- HSC-MS-25-0607
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia
- ClinicalTrials.gov ID
- NCT07060066
- Acronym / sponsor ID
- HSC-MS-25-0607
- Conditions
- Schizophrenia and Related Disorders
- Keywords
- transcranial magnetic stimulation, schizophrenia, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS stimulation | Active comparator | Device: Active rTMS stimulationParticipants 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 comparator | Device: Sham rTMS stimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active rTMS stimulationActive 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 | Active rTMS stimulation |
| Sham rTMS stimulationSham 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 |
Primary outcome
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)
rsFC values will be reported as a Z-score with a range of -1 to 1, with greater absolute values indicating stronger brain connectivity.
3 secondary outcomes
Electrophysiological response as indicated by mismatch negativity as assessed by electroencephalography (EEG)
Time frame: 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)
Time frame: baseline, visit 11 (about 2 week after baseline), visit 21 (about 4 weeks after baseline)
Depression as assessed by the Calgary Depression Scale
Time frame: baseline, visit 11 (about 2 week after baseline), visit 21(about 4 weeks after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoming Du, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS stimulation in people with Schizophrenia and Related Disorders, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alina Siatka (713-486-2740, Alina.Siatka@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.