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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

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

Study Summary

This trial looks at whether a different, more intense version of a brain stimulation treatment can help people with depression who haven't responded to other 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.Check my eligibility

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.See study design

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 below

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My condition has not improved despite trying several treatments.

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I am between 18 and 75 years old.

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I have previously undergone rTMS therapy.

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I have been diagnosed with MDD or bipolar II and am currently having a major depressive episode.

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]

This trial's timeline: 3 weeks for screening, Varies for treatment, and every day of stimulation, follow-up every 2 weeks after treatment for 6 months by telephone] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage change in Hamilton Depression Rating Scale 21-Item score

Secondary outcome measures

Change from baseline functional connectivity

Change in Beck Depression Inventory (BDI)

Change in Hamilton Rating Scale for Depression (HAMD-17)

+3 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,387 Previous Clinical Trials

17,333,960 Total Patients Enrolled

Gregory Sahlem, MDPrincipal InvestigatorStanford University

7 Previous Clinical Trials

202 Total Patients Enrolled

Nolan Williams, MDPrincipal InvestigatorStanford University

16 Previous Clinical Trials

1,142 Total Patients Enrolled

Media Library

Intermittent Theta-Burst Stimulation (iTBS) (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03680781 — N/A

Major Depressive Disorder Research Study Groups: Accelerated theta burst treatment

Major Depressive Disorder Clinical Trial 2023: Intermittent Theta-Burst Stimulation (iTBS) Highlights & Side Effects. Trial Name: NCT03680781 — N/A

Intermittent Theta-Burst Stimulation (iTBS) (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03680781 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include any participants that are over the age of 35?

"According to the study's guidelines, those between 18 and 75 can enrol. There are 192 studies for minors and 967 for elderly individuals that meet these parameters."

Answered by AI

Am I eligible to enroll in this experiment?

"This medical trial, which is seeking to enroll 90 individuals, requires that applicants have been diagnosed with depressive disorder and are treatment-resistant. Furthermore, they ought to be between 18 - 75 years old."

Answered by AI

Are there any open slots for enrollment in this medical experiment?

"Evidently, this clinical trial is not welcoming participants at present. The study was first posted on April 13th 2018 and the latest update occurred in December 2021. Despite this being inactive, 1295 other medical trials are currently seeking new patients."

Answered by AI