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Behavioural Intervention
High-Dose iTBS for Depression
N/A
Recruiting
Led By Daniel Blumberger, MD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
are between the ages of 18 and 65
have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score for that antidepressant trial of > 3 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF score of 1 or 2 on those 2 separate antidepressants)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 5 treatment days and at 1-week and 4 weeks post-treatment
Awards & highlights
Study Summary
This trial will compare a brain stimulation treatment to a placebo control to see if the brain stimulation treatment can help people with depression.
Who is the study for?
This trial is for outpatients aged 18-65 with major depressive disorder, who haven't responded well to antidepressants or can't tolerate them. Participants must have a certain depression score, be able to follow the treatment schedule, and not be on new psychotropic meds for the last 4 weeks. Exclusions include unstable medical conditions, metal implants near the head, pregnancy, certain psychiatric diagnoses like bipolar or schizophrenia, substance abuse within 3 months, high risk of suicide or taking specific medications.Check my eligibility
What is being tested?
The study tests an accelerated schedule of active intermittent theta burst stimulation (iTBS) against a placebo control over five days. iTBS is a type of repetitive transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate nerve cells in the brain. Depression severity will be measured at multiple points before and after treatment.See study design
What are the potential side effects?
While side effects are not explicitly listed here, rTMS treatments like iTBS may cause headaches or scalp discomfort at the site of stimulation; rare risks include seizures and hearing loss if ear protection isn't used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
My depression hasn't improved after trying at least one strong antidepressant or I couldn't tolerate 2 different ones.
Select...
I am not currently hospitalized.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 5 treatment days and at 1-week and 4 weeks post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 5 treatment days and at 1-week and 4 weeks post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Change on the Beck Depression Inventory-II (BDI-II)
Change on the Generalized Anxiety Disorder 7-Item (GAD-7)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active iTBSExperimental Treatment1 Intervention
Administered 8 times daily at approximately 50 minutes intervals (between session end and start) for 5 days. Each session will deliver 1800 pulses of active iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / ~10 minutes) at a target intensity of 110% of the subject's resting motor threshold.
Group II: Sham iTBSPlacebo Group1 Intervention
Administered 8 times daily at approximately 50 minutes intervals (between session end and start) for 5 days, using a sham coil that reproduces auditory and tactile sensations of stimulation and has an identical external appearance. Each session will deliver 1800 pulses of sham iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / ~10 minutes) at a target intensity of 110% of the subject's resting motor threshold.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoOTHER
1,468 Previous Clinical Trials
484,290 Total Patients Enrolled
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11,826 Patients Enrolled for Depression
Centre for Addiction and Mental HealthLead Sponsor
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80,920 Total Patients Enrolled
84 Trials studying Depression
18,927 Patients Enrolled for Depression
University of British ColumbiaOTHER
1,415 Previous Clinical Trials
2,466,816 Total Patients Enrolled
41 Trials studying Depression
13,138 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had ECT treatment before that did not work for me.I am between 18 and 65 years old.I haven't started or increased any mental health medication in the last 4 weeks.I do not have major brain or nerve conditions like severe head injury, Parkinson's, or multiple sclerosis.I have never received rTMS treatment before.You have been diagnosed with bipolar disorder, schizophrenia, or other related mental health conditions.I have been in stable psychotherapy for at least 3 months with no expected changes.You have thoughts of wanting to harm yourself or take your own life.My main diagnosis is a personality disorder, more impactful than my depression.I do not have a serious unstable illness, pacemaker, or implanted medication pump.I am willing and able to agree to treatment.My depression hasn't improved after trying at least one strong antidepressant or I couldn't tolerate 2 different ones.I am not currently hospitalized.You have been diagnosed with certain mental health conditions like obsessive compulsive disorder, post-traumatic stress disorder, anxiety disorders, or dysthymia, and they are causing more problems for you than depression.You have been diagnosed with substance addiction or abuse within the past 3 months using a specific interview.I take no more than 2 mg of lorazepam daily or any anticonvulsant.You have been diagnosed with Major Depressive Disorder (MDD) by a special interview called the Mini-International Neuropsychiatric Interview (MINI).
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.
Research Study Groups:
This trial has the following groups:- Group 1: Sham iTBS
- Group 2: Active iTBS
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period of this experiment still accessible to participants?
"That is accurate. The clinical trial details published on clinicaltrials.gov demonstrate that this medical study, which was initially posted on February 6th 2020, is still recruiting participants. Approximately 200 individuals must be recruited from 3 distinct sites."
Answered by AI
Has this clinical trial set an age limit for participation?
"This clinical trial has an age limit of 18-65, meaning that all participants must be in this range to be eligible."
Answered by AI
What are the eligibility criteria to partake in this clinical investigation?
"This clinical trial targets 200 outpatients with psychosis and involutional depression ranging from 18-65 years old. Potential participants must possess the capacity to provide informed consent, a score of greater than 18 on the HRSD-17 item scale, no change or initiation in psychotropic medication within 4 weeks prior to screening, have not achieved successful therapeutic results through an adequate dose of antidepressants according to ATHF scoring (a 3 or above), incapable of tolerating two separate antidepressant trials due to inadequate dosage/duration as defined by ATHF scores (1s & 2s) and are willing/able to adhere strictly to the treatment"
Answered by AI
How many participants are currently enrolled in this clinical experiment?
"Affirmative. According to the clinicaltrials.gov website, this research is presently accepting volunteers with a start date of February 6th 2020 and an updated posting from November 30th 2022. This investigation seeks 200 participants distributed across 3 medical sites."
Answered by AI
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