Theta Burst Stimulation for Depression

SS
EC
Overseen ByEmma Cummings
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: The Royal Ottawa Mental Health Centre
Must be taking: Antidepressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how accelerated intermittent Theta Burst Stimulation (iTBS), a type of brain stimulation therapy, can help people with major depressive disorder (MDD). The main goal is to understand how this treatment changes the brain and improves depression symptoms using advanced brain imaging techniques. Individuals diagnosed with MDD, who have tried at least one antidepressant without success, and have maintained a stable treatment plan for at least four weeks, might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially benefit from innovative treatment.

Will I have to stop taking my current medications?

You need to have a stable treatment regimen for at least four weeks before joining the study, which means no changes to your current medications during that time. However, you cannot use benzodiazepines or lithium, but other stable psychotropic medications are allowed.

What prior data suggests that accelerated intermittent Theta Burst Stimulation (iTBS) is safe for treating depression?

Previous studies have shown that intermittent Theta Burst Stimulation (iTBS) is safe for people with major depressive disorder (MDD). Research indicates that iTBS can quickly and safely improve depression symptoms. One study found that both the regular and faster versions of iTBS were well-tolerated by patients, with no major safety issues. Another study found that daily iTBS was as safe as another common treatment, cTBS.

While some studies specifically focused on teenagers, most research supports iTBS as a safe option for adults with depression. Overall, evidence suggests that iTBS is a well-tolerated treatment with a good safety record for those considering joining a clinical trial.12345

Why are researchers excited about this trial?

Unlike traditional depression treatments like antidepressant medications and psychotherapy, accelerated intermittent Theta Burst Stimulation (iTBS) offers a novel approach by using magnetic pulses to stimulate certain brain areas. Researchers are excited because iTBS targets brain circuits directly involved in mood regulation, potentially providing quicker symptom relief. Additionally, this method could enhance synaptic density and improve functional connectivity in the brain, which might lead to more durable improvements in depression symptoms.

What evidence suggests that accelerated intermittent Theta Burst Stimulation (iTBS) might be an effective treatment for depression?

Research has shown that accelerated intermittent Theta Burst Stimulation (iTBS), which participants in this trial will receive, can help individuals with major depressive disorder (MDD). Studies have found that iTBS can quickly and safely reduce depression symptoms. For instance, one study found that 69.2% of patients responded well to the treatment, and 46.2% experienced complete relief from symptoms four weeks after treatment. Another study showed that depression scores dropped by 54.7% in the iTBS group, compared to a 31.87% drop in a group that received a placebo treatment. These results suggest that iTBS is a promising option for easing depression symptoms.13467

Who Is on the Research Team?

ST

Sara Tremblay

Principal Investigator

The Royal's Institute of Mental Health Research

LT

Lauri Tuominen

Principal Investigator

The Royal's Institute of Mental Health Research

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with major depressive disorder who are currently experiencing a depressive episode. Participants should be able to undergo MRI and PET scans, and must not have conditions or implants that make these scans unsafe.

Inclusion Criteria

Referred by their treating physician
Maintained a stable treatment regimen for at least four weeks prior to entering the study with no changes during this period
I am between 18 and 55 years old.
See 5 more

Exclusion Criteria

Breastfeeding or pregnant confirmed via urine test
BMI greater than 30 or less than 18
Positive urine test for illegal substances, cannabis, or cotinine
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo one week of accelerated iTBS treatment with pre- and post-treatment PET/MRI assessments

1 week
Daily visits Monday-Friday

Follow-up

Participants are monitored for changes in synaptic density, functional connectivity, and microstructural integrity after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • accelerated intermittent Theta Burst Stimulation (iTBS)

Trial Overview

The study tests one week of accelerated intermittent Theta Burst Stimulation (iTBS), a type of non-invasive brain stimulation, in people with depression. Brain changes before and after treatment are measured using advanced imaging techniques.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Accelerated iTBSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Royal Ottawa Mental Health Centre

Lead Sponsor

Trials
24
Recruited
2,300+

Citations

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 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40738417/

Efficacy and Safety of Accelerated Intermittent Theta Burst ...

a-iTBS was a safe and effective treatment for adolescents with non-treatment-resistant MDD, but the therapeutic effect diminished at the ...

Accelerated Intermittent Theta Burst Stimulation for ...

This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.

Efficacy and safety of intermittent theta-burst stimulation ...

In patients with MDD, daily iTBS outperformed daily cTBS in terms of antidepressant efficacy, with comparable safety and tolerability profiles ( ...

Theta burst stimulation for depression: a systematic review ...

In clinical practice, theta burst stimulation (TBS) presents as a more efficient and potentially more effective therapeutic modality than ...

Efficacy and safety of intermittent theta-burst stimulation ... - PMC

In patients with MDD, daily iTBS outperformed daily cTBS in terms of antidepressant efficacy, with comparable safety and tolerability profiles ...

Accelerated Theta-Burst Stimulation for Treatment ...

The active aTBS group experienced a mean reduction in Hamilton Depression Rating Scale scores of 54.7% compared to 31.87% in the sham group; ...