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Non-invasive Brain Stimulation
Theta Burst Stimulation for Treatment-Resistant Depression (ciTBS Trial)
N/A
Waitlist Available
Led By Yvette Sheline, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 - 70 years of age
Failed 2+ prior treatments (treatment-refractory)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
ciTBS Trial Summary
This trial will use a new TMS protocol to see if it is more effective than current TMS protocols in treating patients with treatment-resistant depression.
Who is the study for?
This trial is for adults aged 18-70 with major depressive disorder who haven't improved after at least two treatments. They must score ≥20 on a depression scale, speak English, and can consent to treatment. Exclusions include MRI contraindications, implanted medical devices like pacemakers, pregnancy, recent substance abuse issues, or certain neurological conditions.Check my eligibility
What is being tested?
The study tests an accelerated form of magnetic brain stimulation called intermittent Theta Burst Stimulation (iTBS), concentrating the usual 6-week protocol into five days for those with treatment-resistant depression.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. The rapid pace of this specific protocol's side effects are not fully known but will be monitored closely.
ciTBS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Select...
My condition did not improve after two or more treatments.
ciTBS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Depressive Symptoms Change
Secondary outcome measures
Self report Symptom Change
ciTBS Trial Design
1Treatment groups
Experimental Treatment
Group I: Compressed iTBS scheduleExperimental Treatment1 Intervention
Stimulation 3-pulse 50-Hz bursts at 5-Hz for 2-s trains, with trains every 10 s, for 10 minutes, 10 times a day, for 5 consecutive days.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,058 Total Patients Enrolled
Yvette Sheline, MDPrincipal Investigator - University of Pennsylvania
Penn Behavoral Health, University Of Penn-Outpatient Psychiatry Center
Boston University School Of Medicine (Medical School)
Beth Israel Deaconess Hp M C (Residency)
1 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a health condition that makes it difficult to get accurate MRI results.You have been struggling with alcohol or drug addiction in the past three months.My gender does not limit my participation.I am between 18 and 70 years old.You have been diagnosed with major depressive disorder (MDD) according to the standard criteria used by mental health professionals.I have a neurological condition that may affect my treatment, as determined by my doctor.You cannot have an MRI scan for medical reasons.My condition did not improve after two or more treatments.Your score on the Montgomery Asberg Depression Rating Scale is 20 or higher, indicating severe depression.You have a medical device implanted in your body, such as a pacemaker or aneurysm clip.I am taking antidepressants approved by my doctor, at safe levels for TMS.
Research Study Groups:
This trial has the following groups:- Group 1: Compressed iTBS schedule
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I able to enroll in this clinical experiment?
"This experiment seeks 30 subjects with clinical depression aged between 18 and 70 years. These participants must be able to consent, have a score of 20 or higher on the Montgomery Asberg Depression Rating Scale, and display symptoms that indicate failure from at least two prior treatments."
Answered by AI
Is there an ongoing search for participants in this clinical evaluation?
"Per the clinicaltrials.gov data, this study is no longer accepting new participants; initially posted in February 2020 and last updated on July 13th 2022. Nevertheless, there are still 1,149 other trials enrolling patients at present."
Answered by AI
Does this research encompass individuals aged 55 and above?
"This clinical trial is recruiting participants of consenting age (18+) and under 70 years old."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Department of Interventional Psychiatry, University of California San Diego
Center for Neuromodulation in Depression and Stress
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I’ve tried many other drugs, ketamine is not effective; I’m desparate for help.
PatientReceived 2+ prior treatments
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