rTMS + Text4Support for Depression

Recruiting at 1 trial location

Overseen By Vincent Agyapong, MD, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Neurological disorder, Psychotic disorder, Personality disorder, others

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

Compensation: Varies

Number of Visits: 35

Duration: 6 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of two treatments for depression. One group will receive repetitive Transcranial Magnetic Stimulation (rTMS), which uses magnetic fields to stimulate the brain, along with supportive text messages designed to boost mood. The other group will receive only the rTMS treatment. Ideal participants are adults diagnosed with major depressive disorder who have not found relief from at least two previous antidepressant treatments. Participants should also be comfortable with English and have access to a smartphone for the text messages. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options for depression.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. Participants can continue using psychotropic medications like antidepressants, antipsychotics, benzodiazepines, and anticonvulsants during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that repetitive Transcranial Magnetic Stimulation (rTMS) is generally safe. One study found that older adults rarely experienced side effects, and serious issues like worsening depression were uncommon. rTMS uses magnetic fields to improve depression symptoms, proving its effectiveness.

For the Text4Support program, studies suggest it is a safe and helpful addition for people with mental health conditions. Participants receive daily positive text messages to boost mood and well-being. No major safety concerns have been reported with this program.

Both treatments appear well-tolerated, with evidence supporting their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for depression because they combine cutting-edge technology and support to tackle mental health challenges in a unique way. Repetitive Transcranial Magnetic Stimulation (rTMS) uses magnetic fields to stimulate nerve cells in the brain, offering a non-invasive alternative to traditional antidepressants, which often have side effects. The addition of Text4Support provides daily, personalized text messages based on cognitive behavioral therapy principles, aiming to boost mood and provide ongoing mental health support. This dual approach not only targets brain function directly but also offers emotional reinforcement, potentially enhancing treatment outcomes for individuals with depression.

What evidence suggests that this trial's treatments could be effective for depression?

Studies have shown that repetitive Transcranial Magnetic Stimulation (rTMS) can effectively treat depression. In one study, about 36% of participants experienced remission, significantly improving their symptoms. Another study found that rTMS can help prevent depression recurrence in about 85% of people, particularly those with milder symptoms. In this trial, some participants will receive rTMS sessions alone, while others will receive rTMS sessions combined with Text4Support. Research indicates that programs like Text4Support, which use daily text messages based on cognitive behavioral therapy (a type of talk therapy), can provide helpful and affordable mental health support. These texts aim to improve mood and offer ongoing support, making them a useful addition to depression treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Vincent Agyapong, MD, Ph.D

Principal Investigator

Division of Community Psychiatry, University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Major Depressive Disorder (MDD) who haven't improved after trying at least two antidepressant treatments. They must understand English, be able to use a smartphone for texts, and give written consent. It's not for those under 18, pregnant or breastfeeding women, people with learning disabilities, psychotic disorders, personality disorders that affect study participation, involvement in other trials recently, or certain neurological conditions.

Inclusion Criteria

Must have access to a smartphone and be able to receive and read text messages

I am currently taking medication for mental health issues.

Must have a good understanding of the English language

Exclusion Criteria

Having a current personality disorder that may hinder the patient's participation in this research or may have the potential of affecting cognition and ability to fully participate in the study

Having a learning disability as per identified through medical history or by the investigator during the assessment process

Pregnant and breastfeeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Motor Threshold Assessment

Participants undergo motor threshold assessments to determine stimulation intensity for rTMS treatment

1 week

1 visit (in-person)

Treatment

Participants receive 30 sessions of rTMS treatment over 6 weeks. In the experimental group, participants also receive daily supportive text messages via Text4Support.

6 weeks

30 visits (in-person) for rTMS, daily virtual messages for Text4Support

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up evaluations at 1, 3, and 6 months.

6 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)
• Text4Support

Trial Overview

The trial tests if adding Text4Support (a text messaging support system) to repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation treatment for depression, helps more than rTMS alone. Participants are randomly placed into one of these two groups and followed up at intervals after the six-week active treatment phase.

How Is the Trial Designed?

Group I: Enrolment in rTMS sessions plus Text4Support Experimental Treatment 1 Intervention

Participants in the rTMS plus Text4Support group of the study would be assisted by a study team member assigned that purpose to register onto the Text4Support program. The process would require all participants to input their phone numbers into the Text4Support platform that will be used to deliver the daily messages. Starting a day after enrollment, participants will receive daily supportive text messages designed by mental health therapists, clinical psychologists, psychiatrists, and mental health service users. These messages are based on cognitive behavior therapy principles crafted to enhance positively the mood of its users with depressive symptoms and other related mental health problems of concern. The messages will be pre-programmed into a software program that will deliver the messages to participants automatically to the participants' mobile phones at 10 AM (Mountain Time) and 12 PM (Atlantic Time), and each participant will receive these messages continuously for 6 weeks.

Group II: Enrolment in rTMS sessions alone Active Control 1 Intervention

All study participants will be scheduled to receive 30 sessions of rTMS treatment for 6 weeks as pre-established by the Alberta Health Services Strategic Clinical Network for Addiction and Mental Health and Nova Scotia Health.

Repetitive Transcranial Magnetic Stimulation (rTMS) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as rTMS for:

• Depression
• Smoking cessation

Approved in European Union as rTMS for:

• Depression

Approved in Canada as rTMS for:

• Depression

Approved in Japan as rTMS for:

• Depression

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

In a 6-month follow-up study of 31 patients with major depression who completed a 4-week rTMS trial, 63.64% of those who initially did not respond to treatment became late responders, indicating potential for continued improvement after treatment ends.

The study also found a low relapse rate of only 10% among those who initially responded to rTMS, with an overall high rate of maintained response at 90%, suggesting that rTMS can have lasting effects in treating major depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 6-month follow-up study on response and relapse rates following an acute trial of repetitive transcranial magnetic stimulation in patients with major depression. Arici, C., Benatti, B., Cafaro, R., et al.[2022]

High-frequency rTMS targeting the left dorsolateral prefrontal cortex is an effective treatment for acute episodes of major depressive disorder, supported by over 20 years of clinical trials.

While rTMS is effective for unipolar and likely bipolar depression, there is limited evidence for its effectiveness in the maintenance phase of treatment, indicating a need for ongoing research and practitioner education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the clinical use of repetitive transcranial magnetic stimulation in the treatment of depression. Fitzgerald, PB.[2021]

A patient with treatment-resistant depression (TRD) showed unexpected improvement after experiencing a seizure during repetitive transcranial magnetic stimulation (rTMS), suggesting a potential link between seizure activity and therapeutic effects in TRD.

While rTMS is generally safe, known adverse events include headaches and seizures; this case highlights an unusual outcome where a seizure may have contributed to the patient's improvement, warranting further investigation into the mechanisms of rTMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment-Resistant Depression Entering Remission Following a Seizure during the Course of Repetitive Transcranial Magnetic Stimulation. Kim, JW., Bae, KY., Kim, SW., et al.[2020]

Repetitive transcranial magnetic stimulation (rTMS) is generally a well-tolerated treatment for depression, with mild side effects like headaches being the most common, while severe adverse effects are rare.

Special precautions are necessary for certain groups, such as adolescents, pregnant women, and individuals with metal implants, but with proper assessment and monitoring, rTMS can be safely administered to many patients with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. Taylor, R., Galvez, V., Loo, C.[2019]

In a study involving 10 adults with major depressive disorder, long-term maintenance therapy using repetitive transcranial magnetic stimulation (rTMS) showed that 7 participants experienced significant benefits, with some maintaining improvement without additional antidepressant medications.

The treatment was found to be safe, with no serious adverse events reported and a zero seizure rate across 1831 rTMS sessions, suggesting that rTMS could be a viable long-term option for managing depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term maintenance therapy for major depressive disorder with rTMS. O'Reardon, JP., Blumner, KH., Peshek, AD., et al.[2022]

In a study involving 18 subjects with major depression, repetitive transcranial magnetic stimulation (rTMS) for up to 4 weeks was found to be generally safe, with no significant mean deficits in neuropsychologic function or auditory thresholds.

However, two patients experienced mild high-frequency hearing loss, indicating that while rTMS is safe for most, individual responses may vary and warrant further investigation into long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. Loo, C., Sachdev, P., Elsayed, H., et al.[2019]

Transcranial Magnetic Stimulation (TMS), particularly repetitive TMS (rTMS) over the frontal cortex, has been shown to be clinically effective in treating depression, with numerous trials supporting its therapeutic potential over the past two decades.

Despite its effectiveness, there is currently no widely accepted 'gold standard' protocol for rTMS treatment, highlighting the need for further research to optimize factors such as localization, frequency, and intensity for better efficacy and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

UNANSWERED QUESTIONS IN THE TRANSCRANIAL MAGNETIC STIMULATION TREATMENT OF PATIENTS WITH DEPRESSION. Morvai, S., Nagy, A., Kovács, A., et al.[2019]

Repetitive transcranial magnetic stimulation (rTMS) is generally safe for older adults with late-life depression, with only 12.4% reporting any adverse events and serious adverse events occurring in just 1.5% of cases, based on a review of 11 studies involving 353 patients.

The most common adverse events were mild, such as headaches (6.9%) and discomfort at the stimulation site (2.7%), although some serious adverse events, including psychiatric hospitalization and increased suicidal ideation, were noted in case reports, highlighting the need for further research to ensure safety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of repetitive transcranial magnetic stimulation in older adults with depression, a systematic review of the literature. Overvliet, GM., Jansen, RAC., van Balkom, AJLM., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) has been shown to have a clear clinical effect in treating major depressive disorder, particularly with left high-frequency rTMS, based on a review of 24 meta-analyses.

The study suggests that rTMS is a justified treatment option for some patients with depression, while also highlighting the need for further research on its efficacy in different stimulation methods and in patients who have not previously received medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A happiness magnet? Reviewing the evidence for repetitive transcranial magnetic stimulation in major depressive disorder. Pridmore, W., Pridmore, S.[2021]

In a study involving 59 patients with major depression, repetitive transcranial magnetic stimulation (rTMS) did not show significant effectiveness compared to sham treatment, with no meaningful differences in depression scores between the two groups.

While there were slightly higher response and remission rates in the real rTMS group (32% and 25%, respectively) compared to the sham group (10% for both), these differences were not statistically significant, indicating that rTMS may not provide a clear benefit over placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression. Mogg, A., Pluck, G., Eranti, SV., et al.[2022]

In a sham-controlled study involving 29 patients with depression (79% treatment-resistant), fast, left frontal repetitive transcranial magnetic stimulation (rTMS) was found to be more effective than sham treatment, with a response rate of 77% compared to 55% (P<0.05).

The treatment was generally well tolerated, and the improvements in depression symptoms were maintained for up to 12 weeks, suggesting that rTMS could be a valuable addition to existing depression therapies, although further research is needed to optimize treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive fast repetitive transcranial magnetic stimulation in depression. Anderson, IM., Delvai, NA., Ashim, B., et al.[2018]

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