What side effects are associated with this type of intervention?

Common treatments for Major Depressive Disorder (MDD) include neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT), as well as pharmacological treatments. rTMS can cause side effects such as headaches, scalp discomfort, and, rarely, seizures. ECT may lead to short-term memory loss, confusion, and physical side effects like muscle aches. Pharmacological treatments, including antidepressants like SSRIs and SNRIs, often cause side effects such as nausea, weight gain, sexual dysfunction, and insomnia. These side effects vary in intensity and duration among individuals.

What prior FDA approvals exist?

The FDA has approved several neuromodulation treatments for Major Depressive Disorder (MDD). Repetitive Transcranial Magnetic Stimulation (rTMS) is one such treatment, which uses magnetic fields to stimulate nerve cells in the brain and has shown efficacy in patients with treatment-resistant depression. Another approved treatment is Vagus Nerve Stimulation (VNS), which involves electrical stimulation of the vagus nerve to influence mood-regulating brain regions. Additionally, Electroconvulsive Therapy (ECT) is a well-established neuromodulation technique used for severe cases of MDD. These treatments, like aiTBS, aim to modulate neural activity and enhance synaptic plasticity in mood-regulating areas of the brain.

What other types of research exist?

Promising novel alternatives to aiTBS for Major Depressive Disorder include repetitive transcranial magnetic stimulation (rTMS), which has shown efficacy in reducing depressive symptoms, and transcranial direct current stimulation (tDCS), which has demonstrated potential in reducing both positive and negative symptoms in various studies. Electroconvulsive therapy (ECT) remains a highly effective treatment for severe cases of depression, particularly treatment-resistant depression.

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Neurostimulation

Therapeutic Neuromodulation for 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

Male or Female, between the ages of 18 and 80 at the time of screening

Currently diagnosed with Major Depressive Disorder (MDD) 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)

Must not have

History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma

Any history of ECT (greater than 8 sessions) without meeting responder criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-week post-treatment-initiation

Awards & highlights

No Placebo-Only Group

Summary

This trial will study a new treatment using electric pulses to reduce depression symptoms in people who have not been helped by other treatments.

Who is the study for?

This trial is for adults aged 18-80 with Major Depressive Disorder who haven't responded to standard treatments and have a MADRS score of ≥20. Participants must be TMS naive, in good health, agree to lifestyle considerations, and females must use effective contraception. Exclusions include metal implants that interfere with MRI or rTMS, seizure history, psychotic/bipolar disorders, substance abuse, severe personality disorder, recent suicide attempt or ECT without response.

What is being tested?

The study tests an innovative neurostimulation method called accelerated intermittent theta burst stimulation (aiTBS) targeting two brain regions: DMPFC & DLPFC. It aims to alleviate symptoms of anhedonia in treatment-resistant depression by comparing the effects of aiTBS on these areas.

What are the potential side effects?

While not explicitly listed here, typical side effects from similar neuromodulation treatments can include headache or discomfort at the stimulation site. There may also be risks associated with repetitive Transcranial Magnetic Stimulation (rTMS), such as seizures or changes in mood.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 80 years old.

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I have been diagnosed with Major Depressive Disorder and am currently experiencing a major depressive episode.

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My antidepressant dose has been stable for 6 weeks and I agree to keep it the same during the study.

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 serious brain or nerve conditions.

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I've had more than 8 ECT sessions without improvement.

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My treatment's intensity is more than 65% of the maximum level.

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I do not have metal implants in my head, a history of seizures, or known brain lesions.

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My depression symptoms have not worsened by 30% or more recently.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-week post-treatment-initiation 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 clinician-administered MADRS from Baseline to Week 1 post-treatment-initiation

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Active TBS-DLPFCActive Control1 Intervention

The active group will receive theta-burst TMS DLPFC stimulation.

Group II: Active TBS-DMPFCActive Control1 Intervention

The active group will receive theta-burst TMS DMPFC stimulation.

0 / 8Eligibility 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

Common treatments for Major Depressive Disorder (MDD) often target neural activity and synaptic plasticity in mood-regulating brain regions. Traditional antidepressants, such as SSRIs, increase the availability of neurotransmitters like serotonin, enhancing synaptic transmission and promoting neuroplasticity. Transcranial Magnetic Stimulation (TMS) uses magnetic fields to stimulate nerve cells in the brain, which can modulate neural circuits involved in mood regulation. Electroconvulsive Therapy (ECT) induces controlled seizures that can reset neural pathways and improve synaptic plasticity. These mechanisms are crucial for MDD patients as they help restore normal brain function, alleviate depressive symptoms, and improve overall mood and cognitive function.

Pathophysiology of depression: the concept of synaptic plasticity.