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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

Must not have

Diagnosed with acute or chronic psychotic symptoms of disorders (e.g. schizophrenia, schizophreniform, schizoaffective disorder) in the current depressive episode

Has neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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I am between 18 and 70 years old.

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I have been diagnosed with major depression without experiencing psychosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a psychotic disorder like schizophrenia during my current depressive episode.

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I have a neurological condition like epilepsy or a history of severe head trauma.

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I have a history of seizures.

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I am unable to understand and give consent for treatment.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one month prior to initial tms session (baseline) to within one month following the completion of tms treatment (~ 8 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met