rTMS for Depression in Schizophrenia

Overseen By Xiaoming Du, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Stroke, Seizure, Head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how repetitive transcranial magnetic stimulation (rTMS) can reduce depression in people with schizophrenia. rTMS is a non-invasive treatment that uses magnetic fields to stimulate brain nerve cells, aiming to ease depressive symptoms effectively. Participants will receive either the actual rTMS treatment or a sham (fake) version for comparison. The trial seeks individuals with schizophrenia who experience depression and can provide written consent.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on innovative depression treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that rTMS is safe for treating depressive symptoms in schizophrenia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is safe and well-tolerated for individuals with schizophrenia. A review of studies found that people with schizophrenia, who often face unique health challenges, do not have a higher risk of side effects like seizures when using rTMS. This indicates that the treatment is generally safe for them.

Although there is a higher chance of side effects when using rTMS to treat depression, this often relies on self-reported information, which can vary. Overall, rTMS is considered a safe option for treating depressive symptoms in individuals with schizophrenia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about repetitive Transcranial Magnetic Stimulation (rTMS) for depression in schizophrenia because it offers a non-invasive alternative to current treatments like antipsychotics and antidepressants. Unlike medications, which often come with significant side effects, rTMS uses magnetic fields to stimulate nerve cells in the brain, potentially reducing symptoms without the same level of risk. This technique is particularly promising because it can target specific brain areas associated with depression, which might lead to faster and more effective relief for patients. Overall, rTMS could provide a new, side-effect-free option for individuals struggling with this challenging condition.

What evidence suggests that rTMS might be an effective treatment for depression in schizophrenia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can help reduce negative symptoms in people with schizophrenia. In this trial, participants will receive either active rTMS stimulation or sham rTMS stimulation. One study found that active rTMS was more effective than sham treatment in reducing these symptoms, with a noticeable difference. Additionally, rTMS has improved brain functions like memory and language in people with schizophrenia. For depression, rTMS has shown promise in relieving symptoms, especially when other treatments have failed. Overall, these findings suggest that rTMS could effectively treat depressive symptoms in schizophrenia. ^{1 2 4 6 7}

Who Is on the Research Team?

Xiaoming Du, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with schizophrenia and depression, as indicated by a score of ≥3 on the Calgary depression scale. Participants must be able to consent and not have significant substance use issues, major medical conditions affecting brain function, or pregnancy. They also must pass a TMS safety questionnaire.

Inclusion Criteria

Score of Calgary depression scale for schizophrenia (CDSS) ≥ 3

Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10

I am 18 or older and can sign a consent form.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham rTMS via the H4 coil for up to 20 treatment visits over about 4 weeks

4 weeks

20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview The study tests whether rTMS (a non-invasive procedure that uses magnetic fields) can alleviate depressive symptoms in schizophrenia patients. It involves comparing active rTMS stimulation against sham (placebo) stimulation to see if there's an improvement in symptoms.

How Is the Trial Designed?

Group I: Active rTMS stimulation Active Control 1 Intervention

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.

Group II: Sham rTMS stimulation Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37788803/

Effectiveness of Repetitive Transcranial Magnetic ... rTMS was superior to sham in the reduction of negative symptoms of schizophrenia (mean difference [MD]: 0.47; 95% CI, 0.23-0.7; P < .0001).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178124000155

Efficacy of repetitive transcranial magnetic stimulation ... Most reviews indicate that rTMS has an effect on negative symptoms, executive function, working memory, and language function in patients with schizophrenia.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6738665/

Efficacy of repetitive transcranial magnetic stimulation in ... This article gives an overview of the efficacy of repetitive TMS in treatment-resistant depression with the recent evidence.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2825941

Repetitive Transcranial Magnetic Stimulation for Auditory ... Findings In this randomized clinical trial of 62 patients with schizophrenia and AVH, active rTMS was superior to sham treatment in alleviating ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X07000022

A study of the effectiveness of bilateral transcranial ... No substantial benefit of high-frequency bilateral rTMS was seen in the treatment of the negative symptoms of schizophrenia.

6. academic.oup.com academic.oup.com/schizophreniabulletin/article/51/2/392/7758322

Safety of rTMS for Schizophrenia: A Systematic Review and ... rTMS is safe and well tolerated for people with schizophrenia. Individuals with schizophrenia are not at increased risk for adverse effects, including seizure.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5925584/

Meta-analysis of the Efficacy and Safety of Repetitive ... The results of this study show that rTMS treatment of depression has a higher incidence rate of side effects, because the included studies use selfreporting ...