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Behavioural Intervention

Rapid Acting TMS for Depression and Suicide Ideation

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

Diagnosed with Major Depressive Disorder (MDD) or Bipolar Affective Disorder II (BAPD II), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).

Age 22-65 year old at the time of screening on voluntary or involuntary hold

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

Awards & highlights

Study Summary

This trial found that aiTBS may reduce explicit and implicit suicidal cognition in people with MDD.

Who is the study for?

This trial is for adults aged 22-65 with major depressive disorder or bipolar II, experiencing suicidal thoughts. They must be TMS naive, in good health, and agree to use contraception if applicable. Excluded are those with certain mental disorders, substance abuse issues, metal implants or shrapnel in the head, seizures history, severe insomnia or who are pregnant.Check my eligibility

What is being tested?

The study tests accelerated intermittent theta-burst stimulation (aiTBS) against a sham treatment to see its effect on brain networks related to suicidal thinking in depressed patients. Participants will receive either real aiTBS or a placebo-like version without active stimulation.See study design

What are the potential side effects?

While not explicitly listed here, typical side effects of TMS may include headache, scalp discomfort at the site of stimulation, lightheadedness and rare risk of seizure. Other potential risks should be discussed with the research team.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Major Depressive Disorder or Bipolar II.

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I am between 22 and 65 years old.

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I haven't used ketamine for my current depressive episode.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (day 0) and at post-inpatient treatment completion (day 2-7) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in suicidal ideation as measured by the modified Scale for Suicide Ideation (m-SSI).

Secondary outcome measures

Rates of remission immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.

Rates of response immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Left Dorsolateral Prefrontal Cortex (L-DLPFC)Active Control1 Intervention

The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (DLPFC)

Group II: Sham StimulationPlacebo Group1 Intervention

Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,250 Total Patients Enrolled

David Spiegel, MDPrincipal InvestigatorStanford University

10 Previous Clinical Trials

1,637 Total Patients Enrolled

Media Library

Accelerated Theta Burst Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05100004 — N/A

Major Depressive Disorder Research Study Groups: Left Dorsolateral Prefrontal Cortex (L-DLPFC), Sham Stimulation

Major Depressive Disorder Clinical Trial 2023: Accelerated Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT05100004 — N/A

Accelerated Theta Burst Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05100004 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors eligible for the ongoing research project?

"Those between 18 and 75 years old are welcome to apply for this medical trial. For minors, there are 238 clinical trials available, whereas 1058 studies accommodate those aged 65 or older."

Answered by AI

Could I potentially join this research endeavor?

"This medical trial is recruiting 100 participants aged 18 to 75 diagnosed with Major Depressive Disorder (MDD) or Bipolar Affective Disorder II (BAPDII). All applicants must have a score of ≥9 on the SSI-M, be TMS naive, in good general health as assessed by their medical history, scheduled for psychiatric evaluation, able to read and understand informed consent documentation before screening. Additionally they must meet the threshold on MADRS and HAMD-17 at baseline with total scores greater than 20 and not present signs of mania or psychosis. Lastly they should demonstrate compliance with study protocol requirements and willingness to communicate adverse events"

Answered by AI

Are there vacancies available for potential participants of this research?

"Per clinicaltrials.gov, this medical study has opened its recruitment window on November 7th 2021 and is still actively seeking applicants since the last update made to it on May 5th 2022."

Answered by AI

How many participants are being included in this clinical research?

"Indeed, the information made available on clinicaltrials.gov affirms that this research is currently recruiting volunteers. Launched on November 7th 2021 and last updated May 5th 2022, 100 participants are sought from a single trial site."

Answered by AI

Who else is applying?

What site did they apply to?

Stanford Hospital

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

As I stated in previous email message, I have tried six medications and three therapy modalities, which have only served to worsen my symptoms. I am at wit's end.

PatientReceived 2+ prior treatments

I’ve been on so many medication throughout my life, and it seem like some would work for a period of time, and then nothing. At this time my psychologist says that I am medication resistant, and I am more than willing to try anything new in therapy wise, that might be able to help fix my broken brain I just, I want to be able to feel normal within my head and I don’t right now.

PatientReceived no prior treatments