Your session is about to expire
← Back to Search
Brain Stimulation
Accelerated Theta Burst for Treatment-Resistant Depression
N/A
Waitlist Available
Led By Gregory Sahlem, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must qualify as 'moderate or severe treatment refractory' using the Maudsley staging method
Male or female, 18 to 75 years of age
Must not have
History of epilepsy
Any neurological conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every day of stimulation, follow-up every 2 weeks after treatment for 6 months by telephone]
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a faster brain stimulation treatment for people with depression who don't respond to usual treatments. The treatment uses magnetic pulses to activate underactive brain areas and improve mood. This method has been explored as an alternative treatment for depression, particularly for patients who do not respond to usual treatments.
Who is the study for?
This trial is for adults aged 18-75 with Major Depressive Disorder or bipolar disorder type 2, currently in a depressive episode and haven't improved with standard treatments. They must have tried rTMS before, be on a stable antidepressant dose for 6 weeks prior, and continue it during the study. Participants need to have a consistent psychiatrist throughout the trial.
What is being tested?
The study tests an accelerated schedule of intermittent theta-burst stimulation (iTBS) as a re-treatment for those who didn't respond to regular depression therapies. It's an open-label design, meaning everyone knows they're getting iTBS without any placebo control.
What are the potential side effects?
While specific side effects are not listed here, iTBS can sometimes cause headaches or discomfort at the stimulation site. Rarely, there might be risks of seizures or temporary hearing issues due to the noise from the machine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition has not improved despite trying several treatments.
Select...
I am between 18 and 75 years old.
Select...
I have previously undergone rTMS therapy.
Select...
I have been diagnosed with MDD or bipolar II and am currently having a major depressive episode.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of epilepsy.
Select...
I have a neurological condition.
Select...
I have a sleep disorder that is not caused by another health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every day of stimulation, follow-up every 2 weeks after treatment for 6 months by telephone]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every day of stimulation, follow-up every 2 weeks after treatment for 6 months by telephone]
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage change in Hamilton Depression Rating Scale 21-Item score
Secondary study objectives
Change from baseline functional connectivity
Change in Beck Depression Inventory (BDI)
Change in Hamilton Rating Scale for Depression (HAMD-17)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Accelerated theta burst treatmentExperimental Treatment1 Intervention
All participants will receive theta-burst TMS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intermittent theta-burst stimulation (iTBS)
2022
N/A
~30
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Neuromodulation therapies for Major Depressive Disorder (MDD), such as Intermittent Theta-Burst Stimulation (iTBS), repetitive transcranial magnetic stimulation (rTMS), and electroconvulsive therapy (ECT), work by modulating neural activity in brain regions associated with mood regulation, particularly the prefrontal cortex. These treatments aim to restore normal brain function and alleviate depressive symptoms by correcting the neural dysfunctions that contribute to depression.
Understanding these mechanisms is important for MDD patients as it highlights how these therapies can target the root causes of their condition, offering potential relief when traditional pharmacotherapy is ineffective.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,484 Previous Clinical Trials
17,516,031 Total Patients Enrolled
Gregory Sahlem, MDPrincipal InvestigatorStanford University
7 Previous Clinical Trials
172 Total Patients Enrolled
Nolan Williams, MDPrincipal InvestigatorStanford University
17 Previous Clinical Trials
1,192 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of epilepsy.My condition has not improved despite trying several treatments.I have a neurological condition.I have been on a stable antidepressant regimen for at least 6 weeks.I have been diagnosed with MDD or bipolar II and am currently having a major depressive episode.I have previously undergone rTMS therapy.My condition is considered hard to treat according to the Maudsley method.I have been on a stable antidepressant regimen for at least 6 weeks.I have a sleep disorder that is not caused by another health condition.I am between 18 and 75 years old.People taking part in the study need to have a psychiatrist they can see regularly throughout the period they're taking part.I have previously undergone rTMS therapy.I have a history of heart issues, including heart attack or surgery.I have been diagnosed with MDD or bipolar II and am currently having a major depressive episode.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Accelerated theta burst treatment
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.