Rapid Acting TMS for Suicide Ideation in Depression

Not Applicable

Recruiting

• Conditions: Suicide; Depressive Disorder, Major
• Interventions: Device: Accelerated Theta Burst Stimulation; Device: Sham Stimulation

• Registration Number: NCT05100004
• Lead Sponsor: Stanford University

Brief Summary

This study evaluates the effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), on the neural networks underlying explicit and implicit suicidal cognition in inpatients with major depressive disorder.

Detailed Description

Investigators recently developed a form of neuromodulation termed Stanford Neuromodulation Therapy (SNT). SNT-induced remission is associated with significant reductions in the functional connectivity of the neural network underlying explicit suicidal cognition (between sgACC-DMN). This project aims to further elucidate the SNT induced neural network changes underlying explicit suicidal cognition.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-29
• Study Start: 2021-11-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

2. Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.

3. 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).

   Endorse suicidal ideation (score ≥9 on the SSI-M).

4. Meet the threshold on the MADRS and HAMD-17 with a total score of >/=20 at baseline.

5. Not in a current state of mania (Young Mania Rating Scale) or psychosis (MINI)

6. Have to be TMS naive

7. In good general health, as ascertained by medical history.

8. Scheduled with a psychiatrist

9. Access to clinical rTMS after hospital discharge

10. If participant is of childbearing potential and not already pregnant, must agree to use adequate contraception prior to study and for the duration of study participation.

11. No recent use (for the actual depressive episode) of rapid acting antidepressive agent (ketamine)

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Exclusion Criteria

1. Any abnormalities indicated on previous MRI scans e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke affecting stimulated area or connected areas or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results.
2. Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
3. History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
4. Shrapnel or any ferromagnetic item in the head.
5. Pregnancy: The effects of rTMS on the developing human fetus are incipient and still uncertain (25). Pregnant women will not be enrolled into this study. Women of childbearing potential must agree to use adequate contraception (hormonal / barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Females of childbearing-age, will have a pregnancy test prior to receiving each rTMS stimulation session. Should a woman become pregnant or suspects she is pregnant while participating in this study, she should inform study staff.
6. Autism Spectrum disorder
7. A diagnosis of obsessive-compulsive disorder (OCD)
8. The presence or diagnosis of prominent anxiety disorder, personality disorder, or dysthymia
9. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
10. Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
11. Cognitive impairment (including dementia)
12. Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
13. Current mania or psychosis
14. Bipolar Affective Disorder I and primary psychotic disorders.
15. Showing symptoms of withdrawal from alcohol or benzodiazepines
16. IQ<70
17. Parkinsonism or other movement d/o determined by PI to interfere with treatment
18. Desirous of getting ECT and previous intolerant exposure to ECT
19. Any other indication the PI feels would comprise data
20. No access to clinical rTMS after discharge.
21. Previous TMS exposure.
22. Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Dorsolateral Prefrontal Cortex (L-DLPFC)	Accelerated Theta Burst Stimulation	The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (DLPFC)
Sham Stimulation	Sham Stimulation	Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region

Primary Outcome Measures

Name	Time	Method
Change in suicidal ideation as measured by the modified Scale for Suicide Ideation (m-SSI).	At baseline (day 0) and at post-inpatient treatment completion (day 2-7)	The modified Scale for Suicide (m-SSI) is an 18-item clinician rated scale that measures suicidal ideation. Each item is scored from 0-3. Scores are summed for 1 total score. Higher scores indicate more severe suicidal ideation. Investigators will assess change in m-SSI scores at the post-inpatient treatment completion (day 2-7).

Secondary Outcome Measures

Name	Time	Method
Rates of remission immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.	At baseline (day 0) and at post-inpatient treatment completion (day 2-7)	The Montgomery-Åsberg Depression Rating Scale (MADRS), is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.; Remission is defined as MADRS ≤10.
Rates of response immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.	At baseline (day 0) and at post-inpatient treatment completion (day 2-7)	The Montgomery-Åsberg Depression Rating Scale (MADRS), is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.; Response is defined as a reduction of \>/=50% of MADRS baseline score.

Trial Locations

Locations (1)

Stanford Hospital; 🇺🇸 Stanford, California, United States