Depression and SuicideaTBSNCT03601117
Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms
A study testing Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation and Anterior Cingulate Cortex Accelerated Theta Burst Stimulation in people with Depression and Suicide, run by Stanford University at 1 site in United States.
Trial summary
This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients. A small pilot study (n=22) will be carried out to demonstrate feasibility, using the FDA-approved stimulation site for depression treatment (L-DLPFC). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Depression and Suicide
- What is being tested?
- Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation and Anterior Cingulate Cortex Accelerated Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- 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.
- Currently diagnosed with Major Depressive Disorder (MDD) and/or in a current major depressive episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Currently an inpatient at Stanford Hospital
- Meet the threshold on the total HAMD17 score of >/=20 at screening/baseline.
- Qualifies and has access to outpatient rTMS treatment
Who cannot join
- Any structural lesion e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke effecting 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
- Autism Spectrum disorder
Show all 17Show fewer
- Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
- 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
- Cognitive impairment (including dementia)
- Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)
- Current mania
- Current unmanageable psychosis
- IQ <70
- Showing symptoms of withdrawal from alcohol or benzodiazepines
- Parkinsonism or other movement d/o determined by PI to interfere with treatment
- More subcortical lesions than would be expected for age or a stroke effecting stimulated area or connected areas.
- Any other indication the PI feels would comprise data.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.
A small pilot study (n=22) will be carried out to demonstrate feasibility, using the FDA-approved stimulation site for depression treatment (L-DLPFC). Participants will be offered stimulation at the anterior cingulate cortex (ACC).
Read the detailed description
This study intends to investigate whether modifying stimulation parameters enables typical 6-8 week long rTMS protocols to be compressed to only five days. The influence of this accelerated protocol on the length of patient stay in the hospital will be investigated.
- Conditions
- Depression and Suicide
- Being tested
- Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation, Anterior Cingulate Cortex Accelerated Theta Burst Stimulation
- Medical subject headings
- Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsolateral Prefrontal Cortex Accelerated Theta Burst StimulationDevice
Participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC.
Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered using the Brainsway TMS system.
Anterior Cingulate Cortex Accelerated Theta Burst StimulationDevice
Participants will receive iTBS (intermittent theta burst stimulation) to the anterior cingulate cortex (ACC).
Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered using the Brainsway TMS system.
| Study group | Role | What they receive |
|---|---|---|
| Dorsolateral Prefrontal Cortex | Experimental | The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days. Receives: Device: Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation |
| Anterior Cingulate Cortex | Experimental | The accelerated theta burst stimulation protocol will be applied to the left anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days. Receives: Device: Anterior Cingulate Cortex Accelerated Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery Asberg Depression Rating Scale (MADRS) Score
A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60 (higher scores are more symptomatic).
Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of <10.
Data are presented as a raw score point change.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Secondary outcomes (14)
Change in Scale of Suicidal Ideation (SSI) Score
19-item clinician administered assessment to measure the intensity, pervasiveness, and characteristics of suicidal ideation in adults.
Scores range from 0-38. Higher scores indicate more suicidality.
Data are presented as a raw score point change.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Hamilton Rating Scale for Depression Six Item (HAMD-6) Score
Clinical assessment measuring depressive symptoms. Scores range from 0-24 with scores >5 indicating clinical levels of depressive symptoms (higher scores are more symptomatic).
Data are presented as a raw score point change.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Young Mania Rating Scale (YMRS)
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition.
There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients.
Typical YMRS baseline scores can vary a lot. They depend on the patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2).
Data are presented as a raw score point change.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Beck Depression Inventory II (BDI-II)
The Beck Depression Inventory (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.
Scores: 0-13= minimal depression, 14-19=mild depression, 20-28=moderate depression, 29-63=severe depression.
Data are presented as a raw score point change.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Quick Inventory Depressive Scale-Self Reported (QIDS) Score
Self-report measure of depressive symptoms. The questionnaire consists of 16 questions. Each question can score between 0 to 4 points.
Severity of depression is determined as follows: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Very Severe.
Total scores range from 0-27. Total scores: 0-5= no depression, 6-10= mild depression, 11-15= moderate depression, 16-20= severe depression, 21-27= very severe depression.
The total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV MDD criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes (Rush et al. 2003).
Data are presented as a raw score point change.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS-20) Score
Self-report, 20 item scale to determine patient's insomnia level.
Each question can be scored between 0-3. 0=not bothered at all
slightly bothered moderately bothered severely bothered
Total score is calculated by adding up all questions (i.e. Q1+Q2+...Q20). One missing item is allowed, pro-rate if missing one item....i.e. (sum/count)*20.
Minimum Score = 0 (good); Maximum Score = 60 (bad).
Data are presented as a raw score point change.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Resting-state Recordings and TMS-evoked Potentials in EEG Data.
For the first and last stimulation session, EEG recording will be made before (resting-state EEG) and during (TMS-evoked potentials) the stimulation.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Biomarker Analysis in Patient Blood (Plasma) Samples
Blood (plasma) samples will be collected before and one month after stimulation. Blood collection is conducted by the registered hospital phlebotomist (following same protocol of a routine blood test).
Blood samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, samples will be used for DNA/RNA extraction and analyses will be done to determine potential gene targets. Presence of inflammatory markers (cytokines) will also be determined.
All analyses of blood samples will be conducted in the Open Medicine Institute.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Biomarker Analysis in Patient Stool Samples
Stool samples will be collected before and one month after stimulation. Stool collection is performed by registered hospital nurses.
Stool samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, stool samples will be analyzed for potential biomarkers in the gut microbiome.
All analyses of stool samples will be conducted in the Open Medicine Institute.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Biomarker Analysis in Patient Saliva Samples
Saliva samples will be collected before and one month after stimulation. Saliva collection is performed by registered study personnel.
Saliva samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, saliva samples will be analyzed for cortisol levels.
All analyses of stool samples will be conducted in the Open Medicine Institute.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in th Quality of Life Enjoyment and Satisfaction Questionnaire-short Form Score
15-item self-report questionnaire where each item is scored from very poor=1 to very good=5.
The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score.
The last two items are not included in the total score but are stand-alone items.
The raw total score ranges from 14 (min) to 70 (max).
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Performance on the NIH Toolbox
Neurocognitive assessments delivered through an iPad app
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Immediate Mood Scaler (Ims-12) Depression Subscale Score
Immediate Mood Scaler (IMS) is a newly developed, iPad-deliverable 12-item self-report tool designed to capture current mood states with overall score, and depression and anxiety subscales. Individual item scores range from 1-7, with a total overall score range from 12-84.
Data are presented as a raw score point change in depression subscale score. The depression subscale scores range from 7-49 (higher score indicating worse depression).
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Heart Rate Variability
Measure presence of any change in heart rate variability.
Data is reported as a ratio of low frequency (LF) and high frequency (HF) (LF/HF FFT).
FFT: fast Fourier transform.
Measured: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jul 2018
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression and SuicideStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A small pilot study (n=22) will be an open-label study in which all participants receive stimulation to the L-DLPFC to demonstrate feasibility of delivering this accelerated protocol on an inpatient unit. For participants who do not respond to L-DLPFC stimulation, we will offer an alternative site, the ACC. If patients are enrolled that have a psychiatric diagnosis other than MDD, scales measuring symptoms related to their other diagnosis/(es) will also be collected in addition to measuring change in depressive symptoms (see 'other pre-specified outcome measures' for a list of measures used to measure symptoms related to psychiatric diagnoses other than depression).
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nolan R, Stanford University
- Investigators
- Nolan Williams, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601117
- Sponsor's protocol ID
- 41071
- Acronym
- aTBS
- Status last verified
- Apr 2022
- First submitted
- 6 Jul 2018
- Last updated
- 18 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 8684201
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms
- ClinicalTrials.gov ID
- NCT03601117
- Acronym / sponsor ID
- aTBS / 41071
- Conditions
- Depression and Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 10 Aug 2021
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 an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.
A small pilot study (n=22) will be carried out to demonstrate feasibility, using the FDA-approved stimulation site for depression treatment (L-DLPFC). Participants will be offered stimulation at the anterior cingulate cortex (ACC).
Detailed description
This study intends to investigate whether modifying stimulation parameters enables typical 6-8 week long rTMS protocols to be compressed to only five days. The influence of this accelerated protocol on the length of patient stay in the hospital will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A small pilot study (n=22) will be an open-label study in which all participants receive stimulation to the L-DLPFC to demonstrate feasibility of delivering this accelerated protocol on an inpatient unit. For participants who do not respond to L-DLPFC stimulation, we will offer an alternative site, the ACC. If patients are enrolled that have a psychiatric diagnosis other than MDD, scales measuring symptoms related to their other diagnosis/(es) will also be collected in addition to measuring change in depressive symptoms (see 'other pre-specified outcome measures' for a list of measures used to measure symptoms related to psychiatric diagnoses other than depression).
| Arm | Type | Receives |
|---|---|---|
| Dorsolateral Prefrontal Cortex | Experimental | Device: Dorsolateral Prefrontal Cortex Accelerated Theta Burst StimulationThe accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days. |
| Anterior Cingulate Cortex | Experimental | Device: Anterior Cingulate Cortex Accelerated Theta Burst StimulationThe accelerated theta burst stimulation protocol will be applied to the left anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years old
- 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.
- Currently diagnosed with Major Depressive Disorder (MDD) and/or in a current major depressive episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Currently an inpatient at Stanford Hospital
- Meet the threshold on the total HAMD17 score of >/=20 at screening/baseline.
Key exclusion criteria (17 listed)
- Any structural lesion e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke effecting 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
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 |
|---|---|---|
| Dorsolateral Prefrontal Cortex Accelerated Theta Burst StimulationParticipants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Brainsway TMS system. | Device | Dorsolateral Prefrontal Cortex |
| Anterior Cingulate Cortex Accelerated Theta Burst StimulationParticipants will receive iTBS (intermittent theta burst stimulation) to the anterior cingulate cortex (ACC). Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Brainsway TMS system. | Device | Anterior Cingulate Cortex |
Primary outcome
Change in Montgomery Asberg Depression Rating Scale (MADRS) Score
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60 (higher scores are more symptomatic). Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of <10. Data are presented as a raw score point change.
14 secondary outcomes
Change in Scale of Suicidal Ideation (SSI) Score
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Hamilton Rating Scale for Depression Six Item (HAMD-6) Score
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Young Mania Rating Scale (YMRS)
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Beck Depression Inventory II (BDI-II)
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Quick Inventory Depressive Scale-Self Reported (QIDS) Score
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS-20) Score
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Resting-state Recordings and TMS-evoked Potentials in EEG Data.
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Biomarker Analysis in Patient Blood (Plasma) Samples
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Biomarker Analysis in Patient Stool Samples
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Biomarker Analysis in Patient Saliva Samples
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in th Quality of Life Enjoyment and Satisfaction Questionnaire-short Form Score
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Performance on the NIH Toolbox
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Immediate Mood Scaler (Ims-12) Depression Subscale Score
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Heart Rate Variability
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- 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.
Nolan Williams, 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 Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation and Anterior Cingulate Cortex Accelerated Theta Burst Stimulation in people with Depression 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 18 May 2022. 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. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Montgomery Asberg Depression Rating Scale (MADRS) Score (time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)). 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 NCT03601117, which also lists 3 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 18 May 2022.