Using rTMS with and without supportive text messages to treat resistant depression
Repetitive Transcranial Magnetic Stimulation With and Without Text4Support for the Treatment of Resistant Depression: Patient-centered Multicentral Randomized Controlled Pilot Trial. Protocol.
This study is testing if adding supportive text messages to a brain treatment can help adults with tough-to-treat depression feel better compared to just the brain treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Trial ID | NCT05570344 on ClinicalTrials.gov |
What this trial studies
This multicenter pilot trial investigates the effectiveness of repetitive transcranial magnetic stimulation (rTMS) combined with a supportive text messaging program called Text4Support compared to rTMS alone in treating patients with treatment-resistant depression (TRD). Participants aged 18 and older, who have not responded to at least two standard antidepressant treatments, will be randomly assigned to one of the two treatment arms. The study will involve six weeks of active treatment followed by observation periods at one, three, and six months. The primary outcome will be measured using the Patient Health Questionnaire (PHQ-9) to assess changes in depression severity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with major depressive disorder who have failed at least two standard antidepressant treatments.
Not a fit: Patients under 18 or those with certain neurological or psychotic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from treatment-resistant depression.
How similar studies have performed: While the combination of rTMS and supportive text messaging is a novel approach, previous studies have shown rTMS to be effective for depression, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged 18 and above and diagnosed with MDD based upon the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and who have at least failed two or more standard antidepressant treatments during the current episode. Participants may be on psychotropic medications including antidepressants, antipsychotics, benzodiazepines, and anticonvulsants. They must have a good understanding of the English language. Must have access to a smartphone and be able to receive and read text messages. Must be willing to provide written informed consent upon acceptance into the study. Exclusion Criteria: * Patients below the age of 18. * Having diagnosis such as the following conditions (current unless otherwise stated): A neurological disorder, including a history of seizures, having primary or secondary tumors in the central nervous system, cerebrovascular disease, stroke, cerebral aneurysm, movement disorder, * Having a current psychotic disorder such as substance-induced psychosis, psychotic disorder due to a medical condition, or MDD with psychotic features at the time of screening * 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. * Participants involved in any drug or device clinical trial within the last six weeks before the screening visit and/or involvement in another clinical trial for the duration of this study. * Pregnant and breastfeeding women. * Identification and/or the sudden appearance of any condition or instance from the mentioned above and based on the expertise of the investigators that have the potential to hinder the progress and completion and/or become a confounding factor on the outcome assessments.
Where this trial is running
Edmonton, Alberta and 1 other locations
- Edmonton Mental Health Clinic — Edmonton, Alberta, Canada (Recruiting)
- Nova Scotia Health - Abbie J. Lane Memorial Building QEII Health Sciences Centre — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Principal investigator: Vincent Agyapong, MD, Ph.D — Division of Community Psychiatry, University of Alberta
- Study coordinator: Vincent Agyapong, MD, Ph.D
- Email: agyapong@ualberta.ca
- Phone: 780-215-7771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.