Accelerated TBS for Suicidality

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Schizophrenia, Epilepsy, Psychotic symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 7-10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether accelerated Thetaburst Stimulation (aTBS) can reduce suicidal thoughts in individuals hospitalized for major depressive disorder (MDD). Participants will receive either the real treatment or a placebo (inactive treatment) and will undergo up to five treatment sessions daily while completing mood surveys. This study suits those currently hospitalized for suicidal thoughts who have not previously tried TMS (a form of brain stimulation). As an unphased trial, it offers a unique opportunity to contribute to understanding new treatment options for MDD.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that accelerated Thetaburst stimulation is safe for treating suicidal ideation?

Research shows that accelerated thetaburst stimulation (aTBS) is generally safe. In past studies, this treatment did not raise any major safety concerns. Participants tolerated it well, even with multiple daily sessions. No serious side effects were reported, and it helped reduce suicidal thoughts.

Although specific details for this study are not yet available, findings from other research suggest that aTBS is a well-tolerated option for prospective trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about accelerated Thetaburst Stimulation (acTBS) for suicidality because it offers a unique, rapid approach to treatment. Unlike traditional medications for suicidality, which can take weeks to become effective, acTBS has the potential to deliver results in just days. This technique uses magnetic pulses to target specific brain regions involved in mood regulation, offering a non-invasive and potentially faster alternative to antidepressants or psychotherapy. Additionally, the accelerated schedule of multiple daily sessions could enhance its efficacy and provide quicker relief for individuals in crisis.

What evidence suggests that accelerated Thetaburst stimulation could be an effective treatment for suicidal ideation?

This trial will compare accelerated theta burst stimulation (aTBS) with a sham treatment to evaluate their effects on reducing suicidal thoughts. Studies have shown that aTBS can help reduce suicidal thoughts, especially when applied to the left side of the brain. Research indicates that patients' mood scores improved after receiving aTBS, suggesting it might be a promising option for those struggling with suicidal thoughts. Although the results are encouraging, further research is needed to confirm its effectiveness. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for inpatients aged 18-65 with major depressive disorder (MDD) and current suicidal thoughts, who have never had TMS treatment before. They must pass a safety questionnaire to participate. People with borderline personality disorder, past brain stimulation treatments, schizophrenia spectrum disorders, epilepsy or other major neurological issues can't join.

Inclusion Criteria

No safety concerns endorsed on the Screening 13-item Questionnaire for rTMS Candidates

I have never undergone TMS treatment.

There are no safety concerns endorsed on the Screening 13-item Questionnaire for rTMS Candidates.

Exclusion Criteria

Concomitant major unstable medical illness

Any exclusion on the 13-item Questionnaire for rTMS Candidates

You are currently not using any drugs or substances that affect your mind or mood.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Treatment

Participants receive up to 5 sessions of accelerated continuous theta-burst stimulation (acTBS) daily for 4-6 days

7-10 days

Daily sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• accelerated Thetaburst stimulation
• Sham Comparator

Trial Overview The study tests accelerated Thetaburst stimulation (a type of Transcranial magnetic stimulation) on patients with suicidality. Participants are randomly assigned to either real TMS or a sham (fake) treatment over 7-10 days and will complete mood surveys to track changes.

How Is the Trial Designed?

Group I: Active acTBS Active Control 1 Intervention

For the first three treatments, the study psychiatrist will set treatment intensity to 90% MT, and gradually increase intensity to 120% MT over 20 seconds to maximize tolerability. Subsequent treatment sessions (treatment 4 and onward) will begin, and remain, at 120% MT. Treatment will occur 4-5 times a day, separated by an at least 45-min interval between sessions on consecutive weekdays.

Group II: Sham Placebo Group 1 Intervention

All parameters will be programmed in the same way as active treatment, however, the treatment will be delivered on the side of the coil that has an internal (hidden) metal shield that will prevent magnetic energy from reaching the skull and brain. Neither the technician, treating physician, nor the patient, will know whether the treatment was delivered from the sham or active side of the coil. The same auditory and tactile cues will be present during active and sham treatment as electrodes will be placed on the scalps of each participant (whether receiving active or sham treatment) that deliver some electrical sensation.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Accelerated intermittent Theta Burst Stimulation (iTBS) was found to be safe and well tolerated in a study of 50 treatment-resistant depressed patients, with no worsening of suicidal ideation observed during the treatment.

The study showed a significant decrease in suicide risk, as measured by the Beck Scale of Suicide Ideation, lasting up to one month after treatment, regardless of whether patients received active or sham stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial. Desmyter, S., Duprat, R., Baeken, C., et al.[2020]

In a study involving 45 patients with major depressive disorder, both active and placebo intermittent theta burst stimulation (aiTBS) led to rapid decreases in suicidal thoughts, indicating a potential for quick intervention.

The reduction in suicidal ideation after placebo aiTBS was linked to significant decreases in brain perfusion in the frontopolar prefrontal cortex, suggesting that even placebo treatments can influence brain activity related to cognitive processes and suicidal thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo aiTBS attenuates suicidal ideation and frontopolar cortical perfusion in major depression. Baeken, C., Wu, GR., van Heeringen, K.[2020]

In a clinical trial involving patients with treatment-resistant depression, both 10 Hz repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS) effectively reduced suicidality, with remission rates of 43.7% and 49.1% respectively, showing no significant difference between the two methods.

There was a strong correlation between reductions in suicidality and overall depression severity, indicating that improvements in suicidal thoughts were linked to greater decreases in depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of high frequency versus theta-burst repetitive transcranial magnetic stimulation on suicidality in patients with treatment-resistant depression. Mehta, S., Downar, J., Mulsant, BH., et al.[2023]

Accelerated intermittent theta burst stimulation (TBS) was found to be safe and well tolerated in 12 suicidal therapy-resistant depressed patients, showing a significant decrease in suicidal ideation over time.

However, the reduction in suicidal thoughts was not definitively linked to the active TBS treatment compared to sham stimulation, indicating that further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acute effects of accelerated repetitive Transcranial Magnetic Stimulation on suicide risk in unipolar depression: preliminary results. Desmyter, S., Duprat, R., Baeken, C., et al.[2022]

In a study involving 81 participants with major depressive disorder, accelerated intermittent theta burst stimulation (iTBS) significantly reduced suicidality and depressive symptoms over a 6-week period, indicating its potential as an effective treatment.

The intervention was found to be safe, with no serious adverse events reported, and showed particularly pronounced anti-suicidal effects in individuals with higher risk profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicidality and relief of depressive symptoms with intermittent theta burst stimulation in a sham-controlled randomized clinical trial. Wilkening, J., Witteler, F., Goya-Maldonado, R.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11043680/

Effect of novel accelerated intermittent theta burst ... These results indicate that 20 Hz aiTBS has promising antisuicidal and antidepressant efficacy in adolescents. A recent study examining 50 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032723000770

Effect of intermittent theta burst stimulation on suicidal ... The current study suggested that daily iTBS of the left DLPFC for 2 weeks could effectively and safely alleviate suicidal ideation and mitigate ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0280010

Sequential bilateral accelerated theta burst stimulation in ... This is the first known randomized controlled trial to examine the efficacy of sequential bilateral aTBS for treating suicidal ideation in adolescents with MDD.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05377177

Study Details | NCT05377177 | Cortical Inhibition as a ... This is a prospective clinical trial to confirm the effectiveness of bilateral accelerated theta burst stimulation (aTBS) on suicidal ideation (SI).

5. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(25)00294-3/fulltext

Accelerated bilateral theta burst stimulation for suicidal ... Subscale analyses further showed marked improvements in both active(Item 4: baseline 1.3 ± 0.7 vs. post-treatment 0.8 ± 0.6; t51 = 5.3, p < 0.001; mean ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5037167/

Accelerated Intermittent Theta Burst Stimulation for Suicide ... Conclusions: This accelerated iTBS protocol was safe. The observed significant decrease in suicide risk was unrelated to active or sham stimulation and ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27729854/

Accelerated Intermittent Theta Burst Stimulation for Suicide ... Conclusions: This accelerated iTBS protocol was safe. The observed significant decrease in suicide risk was unrelated to active or sham ...