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Neurostimulation
Neuromodulation for Treatment-Resistant Depression
N/A
Recruiting
Led By David Spiegel, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently diagnosed with Major Depressive Disorder (MDD) or Bipolar Disorder type II and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5)
Medical records confirming a history of moderate to severe treatment-resistance as defined by a score of 7-14 on the Maudsley Staging Method (MSM)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-week post-treatment-initiation
Awards & highlights
Study Summary
This trial will study if aiTBS can help people with treatment resistant depression or bipolar disorder who have not responded to other treatments. aiTBS is a new application of repetitive transcranial magnetic stimulation (TMS) that has been shown to help 90% of people with severe, treatment resistant MDD in 1-5 days.
Who is the study for?
This trial is for adults aged 18-80 with treatment-resistant depression, defined by a specific score on the Maudsley Staging Method. Participants must be in good health, have ongoing psychiatric care, and women of childbearing age should use effective contraception. Exclusions include substance abuse issues, recent suicide attempts or ideation, certain neurological diseases or head trauma, metal implants incompatible with MRI or rTMS treatments.Check my eligibility
What is being tested?
The study tests an innovative neurostimulation approach called accelerated intermittent theta burst stimulation (aiTBS) targeting different brain regions to alleviate symptoms of severe depression that hasn't responded to standard treatments. It compares active aiTBS at two brain sites versus sham (placebo-like) treatment.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, seizures (rare), temporary hearing changes due to noise during treatment sessions and possible emotional changes such as increased anxiety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with MDD or Bipolar II and am currently experiencing a major depressive episode.
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My medical records show I have moderate to severe treatment-resistant depression.
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I have been on a stable antidepressant regimen for 6 weeks and will continue it during the study.
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I am between 18 and 80 years old.
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I have never undergone TMS therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1-week post-treatment-initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-week post-treatment-initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in clinician-administered MADRS from Baseline to Week 1 post-treatment-initiation
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Active TBS-DLPFCActive Control1 Intervention
The active group will receive theta-burst TMS stimulation.
Group II: Active TBS-DMPFCActive Control1 Intervention
The active group will receive theta-burst TMS stimulation.
Group III: Sham Comparator: Sham TBS-DLPFC or DMPFCPlacebo Group1 Intervention
The sham group will receive sham theta-burst TMS stimulation.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,255 Total Patients Enrolled
David Spiegel, MDPrincipal InvestigatorStanford University
10 Previous Clinical Trials
1,637 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My medical records show I have hard-to-treat depression, scoring 7-14 on the MSM.I have access to psychiatric care before and after the study.I have been diagnosed with MDD or Bipolar II and am currently experiencing a major depressive episode.I have used ketamine or had ECT for depression recently.I don't have metal in my head, a seizure history, or known brain lesions.My medical records show I have moderate to severe treatment-resistant depression.I have never undergone TMS therapy.I have no history of major neurological diseases like dementia, Parkinson's, or brain tumors.I have been on a stable antidepressant regimen for 6 weeks and will continue it during the study.I have been diagnosed with MDD or Bipolar II and am currently experiencing a major depressive episode.I've had more than 8 ECT sessions without improvement.I have ongoing access to psychiatric care.I am between 18 and 80 years old.I have never undergone TMS therapy.I am between 18 and 80 years old.You have a score of 20 or higher on a mood assessment questionnaire completed during the initial screening.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Comparator: Sham TBS-DLPFC or DMPFC
- Group 2: Active TBS-DLPFC
- Group 3: Active TBS-DMPFC
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.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05144789 — 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 study have any age restrictions?
"In order to be eligible for this clinical trial, participants must fall between the ages of 18-80. Out of the 1207 similar trials, 205 are designed specifically for a pediatric population and 1002 cater to geriatric patients."
Answered by AI
Does this clinical trial have any open slots for new participants?
"Yes, this study is still looking for volunteers according to the most recent update on clinicaltrials.gov. The posting date was May 31st, 2022 and the last update was on May 27th, 2022."
Answered by AI
Might I be able to enroll in this experiment?
"Researchers are looking for 100 study participants that have unipolar depression and meet the following eligibility criteria: a MADRS score of ≥20 at screening, lack of TMS treatment history, access to psychiatric care during and after the study, good general health as determined by medical records, male or female between 18-80 years old at time of screening, a history of moderate to severe treatment-resistance according to the Maudsley Staging Method (MSM), and Must be on a stable antidepressant therapeutic regimen for 6 weeks prior to study enrollment."
Answered by AI
What is the maximum amount of people who can be enrolled in this experiment?
"That is correct. The information available on clinicaltrials.gov indicates that this study, which was first posted on May 31st, 2022, is still recruiting patients. They are looking for 100 people to participate at 1 location."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve tried numerous medications over the last 20 years or so, all with subpar results. I am hoping I can find something new that will allow me to move forward in my life.
PatientReceived no prior treatments
I've been struggling with bipolar disorder since I was a teenager, and the biggest challenge is treating my depression. I have frequent recurring bouts of it where medication doesn't seem to treat it completely. I've tried various medications but they never seem to work in the long run. I'd like to try alternative treatment solutions.
PatientReceived 1 prior treatment
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