Depressive Disorder, MajorNCT05100004
Rapid Acting TMS for Suicide Ideation in Depression
A study testing Accelerated Theta Burst Stimulation in people with Depressive Disorder, Major and Suicide, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depressive Disorder, Major, Suicide
- What is being tested?
- Accelerated Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2021to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22-65 year old at the time of screening on voluntary or involuntary hold
- 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.
- 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).
- Meet the threshold on the MADRS and HAMD-17 with a total score of >/=20 at baseline.
- Not in a current state of mania (Young Mania Rating Scale) or psychosis (MINI)
Show all 12Show fewer
- Have to be TMS naive
- In good general health, as ascertained by medical history.
- Scheduled with a psychiatrist
- Access to clinical rTMS after hospital discharge
- 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.
- No recent use (for the actual depressive episode) of rapid acting antidepressive agent (ketamine)
Who cannot join
- 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.
- Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
- History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
- Shrapnel or any ferromagnetic item in the head.
- 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.
- Autism Spectrum disorder
Show all 22Show fewer
- A diagnosis of obsessive-compulsive disorder (OCD)
- The presence or diagnosis of prominent anxiety disorder, personality disorder, or dysthymia
- 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.
- Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
- Cognitive impairment (including dementia)
- Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
- Current mania or psychosis
- Bipolar Affective Disorder I and primary psychotic disorders.
- Showing symptoms of withdrawal from alcohol or benzodiazepines
- IQ<70
- Parkinsonism or other movement d/o determined by PI to interfere with treatment
- Desirous of getting ECT and previous intolerant exposure to ECT
- Any other indication the PI feels would comprise data
- No access to clinical rTMS after discharge.
- Previous TMS exposure.
- Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Acting Transcranial Magnetic Stimulation for Suicide Ideation in Depression
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.
Read the 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.
- Conditions
- Depressive Disorder, Major, Suicide
- Being tested
- Accelerated Theta Burst Stimulation, Sham Stimulation
- Keywords
- suicidality, neuromodulation, transcranial magnetic stimulation, depression
- Medical subject headings
- Depressive Disorder, Major, Suicide, Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Theta Burst StimulationDevice
Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered using the Magventure Magpro X100 TMS system.
Sham StimulationDevice
Participants who are randomly assigned to this group will receive sham stimulation to the left DLPFC.
Sham stimulation will be delivered using the Magventure Magpro X100 TMS system.
| Study group | Role | What they receive |
|---|---|---|
| Left Dorsolateral Prefrontal Cortex (L-DLPFC) | Active comparator | The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (DLPFC) Receives: Device: Accelerated Theta Burst Stimulation |
| Sham Stimulation | Sham comparator | Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in suicidal ideation as measured by the modified Scale for Suicide Ideation (m-SSI).
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).
Measured: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)
Secondary outcomes (2)
Rates of remission immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
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.
Measured: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)
Rates of response immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
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.
Measured: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start7 Nov 2021
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Why it stopped: Transferred
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Spiegel, Stanford University
- Investigators
- David Spiegel, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100004
- Sponsor's protocol ID
- 58808
- Status last verified
- Sep 2025
- First submitted
- 29 Apr 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
PubMed 20439832George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008.
PubMed 8547583Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6.
PubMed 8684201Abdallah CG, Averill LA, Collins KA, Geha P, Schwartz J, Averill C, DeWilde KE, Wong E, Anticevic A, Tang CY, Iosifescu DV, Charney DS, Murrough JW. Ketamine Treatment and Global Brain Connectivity in Major Depression. Neuropsychopharmacology. 2017 May;42(6):1210-1219. doi: 10.1038/npp.2016.186. Epub 2016 Sep 8.
PubMed 27604566Liston C, Chen AC, Zebley BD, Drysdale AT, Gordon R, Leuchter B, Voss HU, Casey BJ, Etkin A, Dubin MJ. Default mode network mechanisms of transcranial magnetic stimulation in depression. Biol Psychiatry. 2014 Oct 1;76(7):517-26. doi: 10.1016/j.biopsych.2014.01.023. Epub 2014 Feb 5.
PubMed 24629537Green KL, Brown GK, Jager-Hyman S, Cha J, Steer RA, Beck AT. The Predictive Validity of the Beck Depression Inventory Suicide Item. J Clin Psychiatry. 2015 Dec;76(12):1683-6. doi: 10.4088/JCP.14m09391.
PubMed 26717528Ballard ED, Reed JL, Szczepanik J, Evans JW, Yarrington JS, Dickstein DP, Nock MK, Nugent AC, Zarate CA Jr. Functional Imaging of the Implicit Association of the Self With Life and Death. Suicide Life Threat Behav. 2019 Dec;49(6):1600-1608. doi: 10.1111/sltb.12543. Epub 2019 Feb 13.
PubMed 30761601Tello N, Harika-Germaneau G, Serra W, Jaafari N, Chatard A. Forecasting a Fatal Decision: Direct Replication of the Predictive Validity of the Suicide-Implicit Association Test. Psychol Sci. 2020 Jan;31(1):65-74. doi: 10.1177/0956797619893062. Epub 2019 Dec 11.
PubMed 31825760Light SN, Bieliauskas LA, Taylor SF. Measuring change in anhedonia using the "Happy Faces" task pre- to post-repetitive transcranial magnetic stimulation (rTMS) treatment to left dorsolateral prefrontal cortex in Major Depressive Disorder (MDD): relation to empathic happiness. Transl Psychiatry. 2019 Sep 3;9(1):217. doi: 10.1038/s41398-019-0549-8.
PubMed 31481688Baeken C, Duprat R, Wu GR, De Raedt R, van Heeringen K. Subgenual Anterior Cingulate-Medial Orbitofrontal Functional Connectivity in Medication-Resistant Major Depression: A Neurobiological Marker for Accelerated Intermittent Theta Burst Stimulation Treatment? Biol Psychiatry Cogn Neurosci Neuroimaging. 2017 Oct;2(7):556-565. doi: 10.1016/j.bpsc.2017.01.001. Epub 2017 Jan 20.
PubMed 29560909Downar J, Geraci J, Salomons TV, Dunlop K, Wheeler S, McAndrews MP, Bakker N, Blumberger DM, Daskalakis ZJ, Kennedy SH, Flint AJ, Giacobbe P. Anhedonia and reward-circuit connectivity distinguish nonresponders from responders to dorsomedial prefrontal repetitive transcranial magnetic stimulation in major depression. Biol Psychiatry. 2014 Aug 1;76(3):176-85. doi: 10.1016/j.biopsych.2013.10.026. Epub 2013 Nov 28.
PubMed 24388670Duprat R, De Raedt R, Wu GR, Baeken C. Intermittent Theta Burst Stimulation Increases Reward Responsiveness in Individuals with Higher Hedonic Capacity. Front Hum Neurosci. 2016 Jun 16;10:294. doi: 10.3389/fnhum.2016.00294. eCollection 2016.
PubMed 27378888Schmaal L, van Harmelen AL, Chatzi V, Lippard ETC, Toenders YJ, Averill LA, Mazure CM, Blumberg HP. Imaging suicidal thoughts and behaviors: a comprehensive review of 2 decades of neuroimaging studies. Mol Psychiatry. 2020 Feb;25(2):408-427. doi: 10.1038/s41380-019-0587-x. Epub 2019 Dec 2.
PubMed 31787757Gartner M, Aust S, Bajbouj M, Fan Y, Wingenfeld K, Otte C, Heuser-Collier I, Boker H, Hattenschwiler J, Seifritz E, Grimm S, Scheidegger M. Functional connectivity between prefrontal cortex and subgenual cingulate predicts antidepressant effects of ketamine. Eur Neuropsychopharmacol. 2019 Apr;29(4):501-508. doi: 10.1016/j.euroneuro.2019.02.008. Epub 2019 Feb 26.
PubMed 30819549
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Acting Transcranial Magnetic Stimulation for Suicide Ideation in Depression
- ClinicalTrials.gov ID
- NCT05100004
- Acronym / sponsor ID
- 58808
- Conditions
- Depressive Disorder, Major, Suicide
- Keywords
- suicidality, neuromodulation, transcranial magnetic stimulation, depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Transferred
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 Nov 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Left Dorsolateral Prefrontal Cortex (L-DLPFC) | Active comparator | Device: Accelerated Theta Burst StimulationThe accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (DLPFC) |
| Sham Stimulation | Sham comparator | Device: Sham StimulationSham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 22-65 year old at the time of screening on voluntary or involuntary hold
- 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.
- 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).
- Meet the threshold on the MADRS and HAMD-17 with a total score of >/=20 at baseline.
Key exclusion criteria (22 listed)
- 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.
- Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
- History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
- Shrapnel or any ferromagnetic item in the head.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated Theta Burst StimulationParticipants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Magventure Magpro X100 TMS system. | Device | Left Dorsolateral Prefrontal Cortex (L-DLPFC) |
| Sham StimulationParticipants who are randomly assigned to this group will receive sham stimulation to the left DLPFC. Sham stimulation will be delivered using the Magventure Magpro X100 TMS system. | Device | Sham Stimulation |
Primary outcome
Change in suicidal ideation as measured by the modified Scale for Suicide Ideation (m-SSI).
Time frame: 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).
2 secondary outcomes
Rates of remission immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
Time frame: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)
Rates of response immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
Time frame: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Background: PubMed 20439832George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
- Background: PubMed 8547583George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008.
- Background: PubMed 8684201Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6.
- Background: PubMed 27604566Abdallah CG, Averill LA, Collins KA, Geha P, Schwartz J, Averill C, DeWilde KE, Wong E, Anticevic A, Tang CY, Iosifescu DV, Charney DS, Murrough JW. Ketamine Treatment and Global Brain Connectivity in Major Depression. Neuropsychopharmacology. 2017 May;42(6):1210-1219. doi: 10.1038/npp.2016.186. Epub 2016 Sep 8.
- Background: PubMed 24629537Liston C, Chen AC, Zebley BD, Drysdale AT, Gordon R, Leuchter B, Voss HU, Casey BJ, Etkin A, Dubin MJ. Default mode network mechanisms of transcranial magnetic stimulation in depression. Biol Psychiatry. 2014 Oct 1;76(7):517-26. doi: 10.1016/j.biopsych.2014.01.023. Epub 2014 Feb 5.
- Background: PubMed 26717528Green KL, Brown GK, Jager-Hyman S, Cha J, Steer RA, Beck AT. The Predictive Validity of the Beck Depression Inventory Suicide Item. J Clin Psychiatry. 2015 Dec;76(12):1683-6. doi: 10.4088/JCP.14m09391.
- Background: PubMed 30761601Ballard ED, Reed JL, Szczepanik J, Evans JW, Yarrington JS, Dickstein DP, Nock MK, Nugent AC, Zarate CA Jr. Functional Imaging of the Implicit Association of the Self With Life and Death. Suicide Life Threat Behav. 2019 Dec;49(6):1600-1608. doi: 10.1111/sltb.12543. Epub 2019 Feb 13.
- Background: PubMed 31825760Tello N, Harika-Germaneau G, Serra W, Jaafari N, Chatard A. Forecasting a Fatal Decision: Direct Replication of the Predictive Validity of the Suicide-Implicit Association Test. Psychol Sci. 2020 Jan;31(1):65-74. doi: 10.1177/0956797619893062. Epub 2019 Dec 11.
- Background: PubMed 31481688Light SN, Bieliauskas LA, Taylor SF. Measuring change in anhedonia using the "Happy Faces" task pre- to post-repetitive transcranial magnetic stimulation (rTMS) treatment to left dorsolateral prefrontal cortex in Major Depressive Disorder (MDD): relation to empathic happiness. Transl Psychiatry. 2019 Sep 3;9(1):217. doi: 10.1038/s41398-019-0549-8.
- Background: PubMed 29560909Baeken C, Duprat R, Wu GR, De Raedt R, van Heeringen K. Subgenual Anterior Cingulate-Medial Orbitofrontal Functional Connectivity in Medication-Resistant Major Depression: A Neurobiological Marker for Accelerated Intermittent Theta Burst Stimulation Treatment? Biol Psychiatry Cogn Neurosci Neuroimaging. 2017 Oct;2(7):556-565. doi: 10.1016/j.bpsc.2017.01.001. Epub 2017 Jan 20.
- Background: PubMed 24388670Downar J, Geraci J, Salomons TV, Dunlop K, Wheeler S, McAndrews MP, Bakker N, Blumberger DM, Daskalakis ZJ, Kennedy SH, Flint AJ, Giacobbe P. Anhedonia and reward-circuit connectivity distinguish nonresponders from responders to dorsomedial prefrontal repetitive transcranial magnetic stimulation in major depression. Biol Psychiatry. 2014 Aug 1;76(3):176-85. doi: 10.1016/j.biopsych.2013.10.026. Epub 2013 Nov 28.
- Background: PubMed 27378888Duprat R, De Raedt R, Wu GR, Baeken C. Intermittent Theta Burst Stimulation Increases Reward Responsiveness in Individuals with Higher Hedonic Capacity. Front Hum Neurosci. 2016 Jun 16;10:294. doi: 10.3389/fnhum.2016.00294. eCollection 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Spiegel, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Theta Burst Stimulation in people with Depressive Disorder, Major and Suicide, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in suicidal ideation as measured by the modified Scale for Suicide Ideation (m-SSI). (time frame: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05100004, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.