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Repetitive Transcranial Magnetic Stimulation
Brain Stimulation for Depression (LeRNIT Trial)
N/A
Recruiting
Led By Fidel Vila-Rodriguez, MD, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be voluntary and competent to consent to treatment
Patients must be outpatients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
LeRNIT Trial Summary
This trial tests if a different kind of brain stimulation works as well as an established one for people with depression that doesn't respond to other treatments.
Who is the study for?
This trial is for adults aged 18-65 with treatment-resistant depression, confirmed by specific criteria and interviews. Participants must have tried antidepressants without success or couldn't tolerate them, score ≥18 on a depression scale, not started new psychotropics recently, and can commit to the schedule. Exclusions include suicidal intent, psychotic/bipolar disorders history, recent substance use, pregnancy, metal head implants, significant medical issues or sensory impairments.Check my eligibility
What is being tested?
The study compares two types of rTMS treatments for depression: low-frequency right-sided (LFR) stimulation versus intermittent theta burst stimulation (iTBS). It aims to determine if LFR is as effective as iTBS in patients who haven't responded well to standard antidepressant therapies.See study design
What are the potential side effects?
rTMS side effects may include discomfort at the stimulation site, headache, lightheadedness or dizziness. Rarely it could cause seizures. Most side effects are mild and improve shortly after treatment sessions.
LeRNIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing and able to agree to treatment on my own.
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I am not currently hospitalized.
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I am either female or male.
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I have been diagnosed with major depression.
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I am between 18 and 65 years old.
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My depression hasn't improved after trying at least one strong antidepressant or two weaker ones.
LeRNIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Anxiety severity
Depression severity
Suicidal ideation
LeRNIT Trial Design
2Treatment groups
Active Control
Group I: Intermittent Theta Burst Stimulation (iTBS)Active Control2 Interventions
iTBS to the L-DLPFC
Group II: Low Frequency Right (LFR)Active Control2 Interventions
1Hz stimulation to the R-DLPFC
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,466,698 Total Patients Enrolled
41 Trials studying Depression
12,918 Patients Enrolled for Depression
Centre for Addiction and Mental HealthOTHER
356 Previous Clinical Trials
81,024 Total Patients Enrolled
85 Trials studying Depression
18,831 Patients Enrolled for Depression
Fidel Vila-Rodriguez, MD, PhDPrincipal InvestigatorUniversity of British Columbia
2 Previous Clinical Trials
120 Total Patients Enrolled
2 Trials studying Depression
120 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been in stable psychotherapy for at least 3 months with no expected changes.I have passed safety screenings for TMS and MRI.I haven't responded well to antidepressants or couldn't tolerate them.I have been diagnosed with major depression.I am willing and able to agree to treatment on my own.I am not currently hospitalized.I am not currently hospitalized.I haven't started or increased any mental health medication in the last month.I am either female or male.I have been diagnosed with major depression.I am between 18 and 65 years old.I have tried ECT for my current health issue without success.My depression hasn't improved after trying at least one strong antidepressant or two weaker ones.I have not had significant neurological issues, seizures (except from ECT), or major head injuries.I am between 18 and 65 years old.I am either female or male.They are able to stick to the treatment schedule.I haven't started or increased any mental health medication in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Intermittent Theta Burst Stimulation (iTBS)
- Group 2: Low Frequency Right (LFR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04999553 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is enrollment in this medical experiment open?
"This medical research is seeking 420 patients with depression and aged between 18-65. In order to be eligible, the patient must have unsuccessfully tried an antidepressant without success (ATHF score > 3), had no change in medication for 4 weeks before screening, willing to comply with treatment plans, possess a HDRS-17 item score of ≥18, and are male or female outpatients that can give their consent."
Answered by AI
How many participants are being recruited for this trial?
"Affirmative, according to clinicaltrials.gov the trial is still recruiting participants after being posted on November 8th 2021 and updated on the same day of that year. The study requires 420 patients to be found across two different sites."
Answered by AI
Are there any upcoming openings for participation in this research endeavor?
"Correct. According to clinicaltrials.gov, this research study is actively enrolling patients after first being posted on November 8th 2021 and updated the same day. From two different medical facilities, 420 participants are desired for this trial."
Answered by AI
Does this research study restrict applicants based on their age?
"This medical trial is only available for individuals aged 18 to 65. For those under the age of consent, there are 192 trials and 970 studies catered towards people over retirement age."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
Centre for Addiction and Mental Health
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
Ontario
New York
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
How frequently would I have to travel to Toronto?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I've tried more than 3 medications for the depression, including Ketamine, and have undergone TMS. None have cleared the depression for more than a short period. I am fully incapacitated at this time.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Centre for Addiction and Mental Health: < 48 hours
Average response time
- < 2 Days
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