40 Participants Needed

Accelerated TBS for Suicidality

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of this treatment for suicidality?

Research shows that accelerated intermittent Theta Burst Stimulation (iTBS) can significantly decrease suicide risk in patients with treatment-resistant depression, with effects lasting up to a month. However, the decrease in suicide risk was observed regardless of whether the active or sham treatment was used, suggesting a strong placebo effect.12345

Is accelerated Theta Burst Stimulation (TBS) safe for humans?

Accelerated Theta Burst Stimulation (TBS) has been found to be safe and well-tolerated in studies involving patients with treatment-resistant depression, with no worsening of suicidal thoughts observed.12345

How does accelerated Theta Burst Stimulation (TBS) differ from other treatments for suicidality?

Accelerated Theta Burst Stimulation (TBS) is unique because it involves a rapid series of magnetic pulses applied to the brain over a short period, specifically targeting the left dorsolateral prefrontal cortex, which is thought to influence mood and suicidal thoughts. Unlike traditional treatments, it is administered intensively over just a few days and has shown a decrease in suicide risk that lasts up to a month, even in patients who do not respond to depression treatments.12345

What is the purpose of this trial?

This is a pilot study to analyze the benefit of accelerated continuous Transcranial magnetic stimulation for inpatient subjects suffering with suicidal ideation. This study will enroll 40 inpatient subjects recruited from the Resnick Neuropsychiatric hospital. Subjects will be blinded and randomized to active or sham TMS treatment and will receive up to 5 assigned treatments per day. Subjects will also be asked to complete mood surveys throughout their participation. Participation in this study will last 7-10 days depending on scheduling.

Eligibility Criteria

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.
See 2 more

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.
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Active acTBSActive Control1 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: ShamPlacebo Group1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Findings from Research

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

References

Effect of high frequency versus theta-burst repetitive transcranial magnetic stimulation on suicidality in patients with treatment-resistant depression. [2023]
Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial. [2020]
Placebo aiTBS attenuates suicidal ideation and frontopolar cortical perfusion in major depression. [2020]
Suicidality and relief of depressive symptoms with intermittent theta burst stimulation in a sham-controlled randomized clinical trial. [2023]
The acute effects of accelerated repetitive Transcranial Magnetic Stimulation on suicide risk in unipolar depression: preliminary results. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security