Clinical trial NCT05100004: Rapid Acting TMS for Suicide Ideation in Depression
Official title: Rapid Acting Transcranial Magnetic Stimulation for Suicide Ideation in Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder, Major
Suicide
Keywords: suicidality
neuromodulation
transcranial magnetic stimulation
depression
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will receive either active or sham stimulation to the DLPFC. Patients will be randomized to either condition with a 50:50 chance.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

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).

Primary outcomes:
measure: Change in suicidal ideation as measured by the modified Scale for Suicide Ideation (m-SSI).
timeFrame: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)
Secondary outcomes:
measure: Rates of remission immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
timeFrame: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)
measure: Rates of response immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
timeFrame: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: David Spiegel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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