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Non-Pharmacological Therapy

rTMS for Treatment-Resistant Depression (BioTMS Trial)

Phase 3

Recruiting

Led By Conor Liston, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 22 to 65 years

At least moderately severe depression (17-item Hamilton Depression Rating Scale greater than or equal to 18)

Must not have

Current depressive episode greater than or equal to 2 years duration

Presence of primary psychiatric diagnoses other than MDD and/or comorbid generalized anxiety disorder (GAD) or phobia (e.g., post-traumatic stress disorder; obsessive-compulsive disorder; MDD w psychotic features; primary psychotic illness; Bipolar I or II)

Timeline

Screening 3 weeks

Treatment 6 weeks

Follow Up 8 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a magnetic brain stimulation treatment for people with depression who don't respond to standard medications. The treatment uses magnetic pulses to target brain areas involved in mood regulation, aiming to improve symptoms. The method has been studied for its effectiveness in treating major depression.

Who is the study for?

Adults aged 22-65 with moderate to severe depression, who haven't improved after trying at least one antidepressant, can join this trial. They must be fluent in English and able to have an MRI safely. Participants should not change their antidepressant dose during the study and must consent to team communication with their clinicians.

What is being tested?

The trial is testing whether brain scans (fMRI) can help optimize rTMS treatment for depression. It explores how rTMS affects brain networks by using these scans before and after therapy sessions.

What are the potential side effects?

rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. Some people might experience temporary hearing changes due to the noise during treatment.

Eligibility Criteria

Inclusion Criteria

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

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I am between 22 and 65 years old.

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I have been diagnosed with moderately severe depression.

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My current depression treatment isn't working despite trying at least one medication.

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My depression medication dose has been stable for at least 4 weeks.

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I am able to understand and agree to the study's requirements.

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I am able to understand and agree to the study's requirements.

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I can safely undergo an MRI scan.

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I am between 22 and 65 years old.

Select...

I have been diagnosed with moderately severe depression.

Select...

My depression hasn't improved after trying at least one antidepressant.

Select...

I have not changed my depression medication dose for at least 4 weeks.

Select...

I am able to understand and agree to the study's requirements.

Select...

I am between 22 and 65 years old.

Select...

I have been diagnosed with moderately severe depression.

Select...

My depression didn't improve after trying at least one antidepressant.

Select...

I have not changed my depression medication dose for at least 4 weeks.

Select...

I understand and can agree to medical procedures.

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I can safely undergo an MRI scan.

Exclusion Criteria

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

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I have been experiencing a depressive episode for 2 years or more.

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I have a mental health condition other than major depression, generalized anxiety, or phobia.

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I have been diagnosed with cognitive impairment.

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I have previously received TMS treatment for my current depressive episode.

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I have had brain surgery for a neurological or mental health issue.

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I do not have a history of serious brain or nerve conditions.

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I have major depression and Vagus Nerve Stimulation didn't work for me.

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I have a history of seizures or take medication that could increase my risk of seizures.

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I am taking more than 300 mg of bupropion daily.

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I am currently taking tricyclic antidepressants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ 6 weeks32 visits

Follow Up ~ 8 weeks0 visits

Screening ~ 3 weeks

Treatment ~ 6 weeks

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, 6 weeks for treatment, and 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

Change in depression, as measured by the Hamilton Depression Rating Scale (HAMD17)

Secondary study objectives

Change in Resting State fMRI Connectivity

Change in depression, as measured by the Quick Inventory of Depressive Symptomology (QIDS)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Targeted Side ArmExperimental Treatment1 Intervention

iTBS rTMS targeting the area of the brain (DLPFC or dorsomedial prefrontal cortex DMPFC)) that we hypothesize will be most effective for that subject's biotype (confirmation arm).

Group II: Standard of CareActive Control1 Intervention

FDA-cleared, standard-of-care iTBS repetitive Transcranial Magnetic Stimulation targeting the left dorsolateral prefrontal cortex (DLPFC), regardless of the depression subtype (biotype) determined by a magnetic resonance imaging (MRI) scan.

Group III: Opposite Side ArmActive Control1 Intervention

iTBS rTMS targeting the opposite site (DLPFC or DMPFC) than the one we hypothesize will be most effective for that subject's biotype (disconfirmation arm).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive Transcranial Magnetic Stimulation

2013

Completed Phase 3

~1170

0 / 28Eligibility criteria met