What side effects are associated with this type of intervention?

Common treatments for Major Depressive Disorder, such as repetitive Transcranial Magnetic Stimulation (rTMS) and Intermittent Theta-Burst Stimulation (iTBS), generally have mild side effects. These can include headaches, scalp discomfort at the stimulation site, and brief episodes of lightheadedness. More rarely, patients may experience seizures, though this is uncommon. Other neuromodulation techniques like electroconvulsive therapy (ECT) can have more significant side effects, including memory loss and confusion. Overall, these treatments are considered relatively safe, with side effects that are typically manageable.

What prior FDA approvals exist?

The FDA has approved several treatments for Major Depressive Disorder that modulate neural activity in brain regions associated with mood regulation. Repetitive Transcranial Magnetic Stimulation (rTMS) is one such treatment, approved for patients who have not responded to traditional antidepressant medications. Additionally, the FDA has approved the use of electroconvulsive therapy (ECT) for treatment-resistant depression. Pharmacological treatments include a range of antidepressants such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and atypical antipsychotics used as adjunctive therapy. These treatments aim to alter brain chemistry and neural activity to alleviate depressive symptoms.

What other types of research exist?

Promising, novel alternatives to Intermittent Theta-Burst Stimulation (iTBS) for Major Depressive Disorder (MDD) patients include: 1) Deep Transcranial Magnetic Stimulation (dTMS), which has shown efficacy in reducing depressive relapses; 2) Low Field Magnetic Stimulation (LFMS), noted for its rapid mood-elevating effects; 3) Transcranial Direct-Current Stimulation (tDCS), which has been associated with cognitive enhancement and mood improvement; and 4) Ketamine and other NMDA antagonists, which have demonstrated rapid antidepressant effects in clinical trials.

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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

Must not have

History of epilepsy

Any neurological conditions

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

No Placebo-Only Group

Summary

This trial tests a faster brain stimulation treatment for people with depression who don't respond to usual treatments. The treatment uses magnetic pulses to activate underactive brain areas and improve mood. This method has been explored as an alternative treatment for depression, particularly for patients who do not respond to usual 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.

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.

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.

Exclusion Criteria

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

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I have a history of epilepsy.

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I have a neurological condition.

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I have a sleep disorder that is not caused by another health condition.

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

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

Primary study objectives

Percentage change in Hamilton Depression Rating Scale 21-Item score

Secondary study objectives

Change from baseline functional connectivity

Change in Beck Depression Inventory (BDI)

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

+3 more

Awards & Highlights

No Placebo-Only Group

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

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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neuromodulation therapies for Major Depressive Disorder (MDD), such as Intermittent Theta-Burst Stimulation (iTBS), repetitive transcranial magnetic stimulation (rTMS), and electroconvulsive therapy (ECT), work by modulating neural activity in brain regions associated with mood regulation, particularly the prefrontal cortex. These treatments aim to restore normal brain function and alleviate depressive symptoms by correcting the neural dysfunctions that contribute to depression. Understanding these mechanisms is important for MDD patients as it highlights how these therapies can target the root causes of their condition, offering potential relief when traditional pharmacotherapy is ineffective.