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Neuromodulation
rTMS for Adolescent Depression
N/A
Recruiting
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Summary
This trial studies if a brain stimulation therapy can help depressed teens by changing how they process emotions.
Who is the study for?
This trial is for boys and girls aged 14-21 with major depression, as defined by the DSM-5. They must have a significant level of depression despite having tried at least one antidepressant treatment, be on a stable medication regimen for 4 weeks prior to the study without changes during it, and be able to follow all study procedures.
What is being tested?
The study tests how rTMS (repetitive Transcranial Magnetic Stimulation), a non-invasive brain stimulation technique, affects emotional processing in depressed adolescents. It starts with one session followed by an open-label phase of active rTMS treatments over four weeks.
What are the potential side effects?
rTMS may cause discomfort at the site of stimulation, headache, lightheadedness or seizures in very rare cases. Most side effects are mild and temporary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recruitment rates
Secondary study objectives
estimating the magnitude of difference detectable in cortico-limbic activity between groups
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active StimulationActive Control1 Intervention
15 Depressed adolescents will undergo emotional processing tasks (within and outside the fMRI scanner) after one session of active rTMS
Group II: Sham StimulationPlacebo Group1 Intervention
15 Depressed adolescents will undergo emotional processing tasks (within and outside the fMRI scanner) after one session of sham rTMS
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,825 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tried at least one antidepressant that didn't work for me.I have an active neurological condition.I have been on a stable antidepressant regimen for over 4 weeks and agree not to change it during the study.I am currently having thoughts about harming myself.I have had seizures at some point in my life.I am between 14 and 21 years old.I have been diagnosed with major depressive disorder.I have undergone rTMS treatment before.I take more than 2 mg of lorazepam or equivalent, or I am on anticonvulsants.
Research Study Groups:
This trial has the following groups:- Group 1: Active Stimulation
- Group 2: Sham Stimulation
Awards:
This trial has 0 awards, including: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.
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