Intermittent Theta Burst Stimulation for Major Depressive Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for major depressive disorder using a brain stimulation method called intermittent theta burst stimulation (iTBS). The researchers aim to determine how iTBS, combined with different medications, affects brain activity and whether it can improve depression symptoms. Participants will receive either active or sham (inactive) iTBS along with study medications to evaluate these combinations. Ideal candidates are those with depression who have not responded well to other treatments and can maintain a stable medication regimen. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that intermittent theta burst stimulation (iTBS) is generally safe and well-tolerated for people with major depressive disorder. Studies indicate that iTBS often causes mild side effects, such as headaches and scalp discomfort, while serious side effects remain rare. For instance, one study found no serious adverse events during iTBS treatment.
Combining iTBS with d-cycloserine has also proven safe. One trial reported no serious side effects with this combination. Similarly, researchers have explored adding dextromethorphan to iTBS, though detailed safety data is limited. However, since the FDA has approved iTBS alone for depression and it is well-tolerated, combining it with these medications is likely to remain safe, based on existing research.
For those considering joining a trial, this information suggests that the treatment has undergone safety studies and is usually well-tolerated by patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about intermittent theta burst stimulation (iTBS) for major depressive disorder because it offers a faster and potentially more effective approach than traditional treatments like SSRIs and cognitive behavioral therapy. iTBS is a form of transcranial magnetic stimulation that delivers short bursts of magnetic pulses to specific brain areas, which might help improve mood more quickly. Additionally, some study arms combine iTBS with medications like D-cycloserine and dextromethorphan, which could enhance its effectiveness by targeting brain chemistry in new ways. This innovative combination of brain stimulation and pharmacology might offer quicker relief with fewer side effects compared to current standard therapies.
What evidence suggests that this trial's treatments could be effective for major depressive disorder?
Studies have shown that Intermittent Theta Burst Stimulation (iTBS) effectively treats major depressive disorder (MDD). Research indicates that iTBS can quickly improve depression symptoms, with symptom reduction rates between 38% and 58%, and full symptom relief rates varying widely. In this trial, some participants will receive iTBS combined with D-cycloserine, which has shown promising results in improving brain communication, leading to high rates of symptom improvement and relief. While iTBS alone is helpful, combining it with D-cycloserine might enhance its effects. Another group in this trial will receive iTBS with dextromethorphan, which researchers are studying for its potential to influence brain communication in depression, although the evidence remains less clear.56789
Who Is on the Research Team?
Joshua C Brown, MD, PhD
Principal Investigator
Mclean Hospital
Are You a Good Fit for This Trial?
This trial is for adults who are either healthy or have major depressive disorder. Participants must be able to safely undergo brain imaging and TMS, and cannot join if they have medical conditions or implants that make these procedures unsafe.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1
Participants complete 4 research visits to test how iTBS changes brain activity in the prefrontal cortex with different medications
Phase 2
Participants with depression receive 30 daily iTBS sessions combined with one blinded study medication
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- D-cycloserine
- Dextromethorphan
- Intermittent Theta Burst Stimulation (iTBS)
- Placebo
- Sham iTBS
Trial Overview
The study tests how a type of brain stimulation called iTBS (a form of TMS) affects the brain in people with and without depression. It also looks at whether two medications—d-cycloserine (increases NMDA activity) and dextromethorphan (decreases NMDA activity)—change the effects of iTBS compared to placebo. Some sessions use sham (inactive) stimulation as a control.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Active TMS and active medication
Active TMS and active medication
Placebo TMS and placebo drug
Active TMS and placebo drug
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mclean Hospital
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
Theta burst stimulation for depression: a systematic review ...
The current study outcomes included the response rate (primary), depression symptom improvement, remission rate, all-cause discontinuation rate, ...
Efficacy study of intermittent theta burst stimulation(iTBS) in ...
The current study suggests that two days of active iTBS to the DLPFC region can rapidly, safely, and effectively improve depressive symptoms in adolescents ...
Intermittent Theta-burst Stimulation for Major Depression ...
It is safe, effective, even for depressed patients unable to respond to standard pharmacological treatment and is more efficient than standard rTMS. In ...
Efficacy and safety of intermittent theta-burst stimulation ...
The therapeutic efficacy and safety profiles of daily or accelerated intermittent theta-burst stimulation (iTBS) in comparison to daily or ...
5.
dovepress.com
dovepress.com/add-on-intermittent-theta-burst-stimulation-improves-the-efficacy-of-f-peer-reviewed-fulltext-article-NDTAdd-on iTBS, recurrent & first episode MDD | NDT
Results: Depressive and anxious symptoms were reduced significantly after the add-on iTBS treatment; the response and remission rates in the ...
Efficacy and safety of intermittent theta-burst stimulation ... - PMC
The therapeutic efficacy and safety profiles of daily or accelerated intermittent theta-burst stimulation (iTBS) in comparison to daily or ...
Intermittent theta burst stimulation for adolescent patients ...
The therapeutic efficacy and safety profile of intermittent theta burst stimulation (iTBS) in adolescent patients with major depressive disorder ...
Accelerated Intermittent Theta Burst Stimulation for ...
This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.
Theta burst stimulation for depression: a systematic review ...
Approximately 69.57% of the trials included individuals with an exclusive diagnosis of major depressive disorder. The following six TBS ...
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