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Behavioural Intervention
rTMS Therapy for Depression (SUNSET Trial)
N/A
Recruiting
Led By Andrew Krystal, MD, MS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing and able to undergo non-invasive brain stimulation
Demonstrate a moderate level of resistance to antidepressant treatment in the current episode, defined as a failure of 1-4 adequate medication trials
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one month prior to initial tms session (baseline) to within one month following the completion of tms treatment (~ 8 weeks)
Awards & highlights
SUNSET Trial Summary
This trial is studying whether certain biomarkers can help predict treatment response to transcranial magnetic stimulation (TMS) in people with Major Depressive Disorder (MDD).
Who is the study for?
This trial is for adults aged 18-70 with Major Depressive Disorder currently experiencing a depressive episode without psychotic features. Participants must have moderate to severe depression, have tried 1-4 antidepressants without success, and be stable on current medications if any. They should be able to undergo non-invasive brain stimulation and commit to research visits for about 8 weeks.Check my eligibility
What is being tested?
The study tests the effectiveness of rTMS therapy in treating Major Depressive Disorder by monitoring changes in brain activity through imaging techniques. It aims to identify reliable biomarkers that can predict treatment response and aid clinical diagnosis.See study design
What are the potential side effects?
rTMS therapy may cause discomfort at the stimulation site, headache, lightheadedness, or tingling. Rarely it could lead to seizures or hearing loss if ear protection isn't used during treatment.
SUNSET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing and able to have a treatment that involves stimulating my brain without surgery.
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I've tried 1-4 antidepressants without success in this episode.
Select...
I am between 18 and 70 years old.
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I have been diagnosed with major depression without experiencing psychosis.
SUNSET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one month prior to initial tms session (baseline) to within one month following the completion of tms treatment (~ 8 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one month prior to initial tms session (baseline) to within one month following the completion of tms treatment (~ 8 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Change in resting state BOLD signal from baseline to end of treatment
Change in resting state EEG from baseline to end of treatment
+1 moreSecondary outcome measures
Change in Beck's Depression Inventory (BDI) score from baseline to end of treatment
Change in Generalized Anxiety Disorder (GAD-7) score from baseline to end of treatment
Change in Inventory of Depressive Symptomatology (IDS-30 self report) score from baseline to end of treatment.
+1 moreSUNSET Trial Design
2Treatment groups
Experimental Treatment
Group I: Morning rTMS treatmentExperimental Treatment1 Intervention
Eligible participants will be assigned to the afternoon treatment group. Prior to the onset of rTMS treatment, EEG scans and magnetic resonance imaging (MRI) sessions including diffusion weighted imaging will be recorded as baseline measures. These measures will also be repeated at treatment midpoint and within one month of rTMS discontinuation in order to track structural and functional changes that occur over the course of treatment. Participants will complete an initial screening followed by 30-40 daily sessions of repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC), completed with their TMS provider.
Group II: Afternoon rTMS treatmentExperimental Treatment1 Intervention
Eligible participants will be assigned to the afternoon treatment group. Prior to the onset of rTMS treatment, EEG scans and magnetic resonance imaging (MRI) sessions including diffusion weighted imaging will be recorded as baseline measures. These measures will also be repeated at treatment midpoint and within one month of rTMS discontinuation in order to track structural and functional changes that occur over the course of treatment. Participants will complete an initial screening followed by 30-40 daily sessions of repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC), completed with their TMS provider.
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,505 Total Patients Enrolled
Andrew Krystal, MD, MSPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
41 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to have a treatment that involves stimulating my brain without surgery.I've tried 1-4 antidepressants without success in this episode.I have been diagnosed with a psychotic disorder like schizophrenia during my current depressive episode.I have a neurological condition like epilepsy or a history of severe head trauma.I have a history of seizures.I am unable to understand and give consent for treatment.I am between 18 and 70 years old.I have been diagnosed with major depression without experiencing psychosis.My mental health medication has not changed recently.I can attend research visits for about 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Morning rTMS treatment
- Group 2: Afternoon rTMS 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve been depressed for many many years and I’m sick and tired of it. I've tried every antidepressant available and even a combination with Adderall. Nothing works to great effect. As a result it's difficult to be fully functional. I'd welcome any viable solution.
PatientReceived 1 prior treatment
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