DepressionNCT04657432
Brief, High-dose rTMS for Depression
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Depression and Anxiety, run by Medical University of South Carolina at 1 site in United States.
Trial summary
High frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to be safe, feasible, and acceptable. Conventionally, rTMS investigations have relied on rational decision trees for dosage determination. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A negative urine pregnancy test, if female subject of childbearing potential.
- Able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits.
- After full explanation of the study, willingness of participant is demonstrated by signing the informed consent form.
Who cannot join
- Clinically unstable medical disease:
- cardiovascular
- renal
- gastrointestinal
- pulmonary
- metabolic
Show all 23Show fewer
- endocrine
- other
- CNS disease deemed progressive
- Moderate or severe traumatic brain injury (TBI)
- Pregnant females or those currently breast-feeding.
- Current or history of schizophrenia or other psychotic disorder, except psychosis not otherwise specified (NOS) when the presence of sensory hallucinations is clearly related to the subject's trauma, Bipolar Type I disorder, or dementia:
- vascular
- Alzheimer's disease
- other types
- Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) within 6 days of study entry, with the exception of alcohol use disorder, which, at the discretion of the study team, may be permitted.
- See further explanation under protection from risk.
- Active participation or plan for enrollment in another evidence-based psychotherapeutic clinical trial
- Participation in other psychotherapeutic modalities must have been stable for 3 months prior to enrollment and must remain stable throughout participation.
- Currently taking medications that have short half-lives, lower the seizure threshold, and do not have evidence of antidepressant efficacy. These include:
- high dose theophylline or stimulants such as methylphenidate patients taking bupropion must be on a stable dose and take less than or equal to 300 mg/day. Stable means the same dose for 5 half-lives.
- An implanted device in subject's head (shunt, cochlear implant) and/or metal in subject's head (other than dental implant).
- History of seizures or a seizure disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve
High frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to be safe, feasible, and acceptable. Conventionally, rTMS investigations have relied on rational decision trees for dosage determination. The purpose of this study is to systematically examine an accelerated protocol of intermittent theta burst (iTBS). Study 1 aims to provide a quantifiable dose-response curve for iTBS and depressive symptom reduction in major depression. Study 2 aims to determine the role of individual variations of their functional networks compared to the site of stimulation and clinical outcomes.
- Conditions
- Depression, Anxiety
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Dose 2 | Experimental | All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 2 is 10 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Dose 3 | Experimental | All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 3 is 15 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Dose 4 | Experimental | All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 4 is 20 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Dose 5 | Experimental | All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 5 is 20 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Dose 6 | Experimental | All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 6 is 25 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Dose 7 | Experimental | All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 7 is 30 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Dose 8 | Experimental | All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 8 is 35 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Dose 9 | Experimental | All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 9 is 40 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Dose 10 | Experimental | All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 10 is 40 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Study 2: 10 Active Doses | Experimental | All participants will be assigned to 10 sessions (per treatment day) of accelerated rTMS for 5 treatment days. All doses are active and within established therapeutic levels of rTMS. Dose 10 is 50 active sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity (change in score)
Depression severity as assessed by:
- Hamilton Scale for Depression (HAM-D) Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. 10 - 13 mild; 14-17 mild to moderate; >17 moderate to severe.
Measured: Day 1, post-treatment point of 1 month
Depression severity (change in score)
Depression severity as assessed by:
- Montgomery-Asberg Depression Rating Scale (MADRS) Rating lies on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5). Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Measured: Day 1, post-treatment point of 1 month
Depression severity (change in score)
Depression severity as assessed by:
- Beck Depression Inventory-II (BDI-II) Rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.
Measured: Day 1, post-treatment point of 1 month
Secondary outcomes (12)
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- Inventory of Depression and Anxious Symptoms (IDAS-II)
-Questions are rated on a scale from 1-5 and covers a wide array of psychological measures
Measured: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- Mood and Anxiety Symptom Questionnaire
-Questions designed to assess symptoms of general distress using a 5-point Likert scale ranging from 1"not at all" to 5 "extremely".
Measured: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- Penn State Worry Questionnaire
-Questions are rated on a scale from: 1-Not at all typical of me to 5-Very typical of me. Possible range of scores is 16-80 with the algorithm of Total scores: 16-39 Low Worry, 40-59 Moderate Worry, and 60-80 High Worry
Measured: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- PTSD Checklist (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including:
Monitoring symptom change during and after treatment Screening individuals for PTSD Making a provisional PTSD diagnosis
-Questions are rated on a 5-point Likert scale (0 = "Not at all" to 4 = "Extremely")
Measured: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- Life Events Checklist (LEC-5) The Life Events Checklist for DSM-5 (LEC-5) is a self-report measure designed to screen for potentially traumatic events in a respondent's lifetime. The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items.
-Responses are as followed: Happened to me; Witnessed it; Learned about it; Part of my job; Not sure; Doesn't apply
Measured: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- Childhood Trauma Questionnaire
-The Childhood Trauma Questionnaire is a brief survey of six early traumatic experiences (death, divorce, violence, sexual abuse, illness or other), and assesses individual's understanding of their childhood trauma.
Measured: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- Fagerstrom Test for Nicotine Dependence
-Yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
Measured: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- Alcohol Use Disorders Identification Test (AUDIT)
-The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems.
Measured: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
-Questions are rated on a a 5 point scale (from 0-4) Likert scale
Measured: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- World Health Organization Quality of Life - Brief Form (WHOQOL-BF)
-Questions are rated on a a 5 point scale (from 1-5) Likert scale
Measured: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- Illness Intrusive Rating Scale (IIRS)
-Questions are rated on a a 7 point scale (from 1-7) Likert scale which is a measure of the psychosocial impact of chronic disease
Measured: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Participants would complete various questionnaires (change in score assessed):
- Quality of Life and Enjoyment and Satisfaction Questionnaire -Short Form (Q-LES-Q-SF)
-Questions are rated on a 5 point scale (from 1-5) Likert scale. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70.
Measured: Day 1, post-treatment point of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start25 May 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Study 1: Participants will be randomized to 10 different doses of accelerated intermittent theta burst rTMS for remediation of depression symptoms. The goal is to determine the optimal dose in terms of efficacy while minimizing burden and side effects. Study 2: Participants will be assigned to 10 active sessions (per treatment day) of accelerated rTMS for 5 treatment days. All doses are active and within established therapeutic levels of rTMS. The goal is to determine the role of individual variations of their functional networks compared to the site of stimulation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657432
- Sponsor's protocol ID
- 00084111
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2020
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve
- ClinicalTrials.gov ID
- NCT04657432
- Acronym / sponsor ID
- 00084111
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- 25 May 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Dec 2020 (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.
High frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to be safe, feasible, and acceptable. Conventionally, rTMS investigations have relied on rational decision trees for dosage determination. The purpose of this study is to systematically examine an accelerated protocol of intermittent theta burst (iTBS). Study 1 aims to provide a quantifiable dose-response curve for iTBS and depressive symptom reduction in major depression. Study 2 aims to determine the role of individual variations of their functional networks compared to the site of stimulation and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 11
- Model description
- Study 1: Participants will be randomized to 10 different doses of accelerated intermittent theta burst rTMS for remediation of depression symptoms. The goal is to determine the optimal dose in terms of efficacy while minimizing burden and side effects. Study 2: Participants will be assigned to 10 active sessions (per treatment day) of accelerated rTMS for 5 treatment days. All doses are active and within established therapeutic levels of rTMS. The goal is to determine the role of individual variations of their functional networks compared to the site of stimulation.
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. |
| Dose 2 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 2 is 10 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. |
| Dose 3 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 3 is 15 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. |
| Dose 4 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 4 is 20 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. |
| Dose 5 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 5 is 20 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. |
| Dose 6 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 6 is 25 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. |
| Dose 7 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 7 is 30 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. |
| Dose 8 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 8 is 35 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. |
| Dose 9 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 9 is 40 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. |
| Dose 10 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 10 is 40 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. |
| Study 2: 10 Active Doses | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants will be assigned to 10 sessions (per treatment day) of accelerated rTMS for 5 treatment days. All doses are active and within established therapeutic levels of rTMS. Dose 10 is 50 active sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A negative urine pregnancy test, if female subject of childbearing potential.
- Able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits.
- After full explanation of the study, willingness of participant is demonstrated by signing the informed consent form.
Key exclusion criteria (23 listed)
- Clinically unstable medical disease:
- CNS disease deemed progressive
- Moderate or severe traumatic brain injury (TBI)
- Pregnant females or those currently breast-feeding.
- Current or history of schizophrenia or other psychotic disorder, except psychosis not otherwise specified (NOS) when the presence of sensory hallucinations is clearly related to the subject's trauma, Bipolar Type I disorder, or dementia:
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex. | Device | Dose 1, Dose 10, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6, Dose 7, Dose 8, Dose 9, Study 2: 10 Active Doses |
Primary outcome
Depression severity (change in score)
Time frame: Day 1, post-treatment point of 1 month
Depression severity as assessed by: 1. Hamilton Scale for Depression (HAM-D) Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. 10 - 13 mild; 14-17 mild to moderate; >17 moderate to severe.
Depression severity (change in score)
Time frame: Day 1, post-treatment point of 1 month
Depression severity as assessed by: 2. Montgomery-Asberg Depression Rating Scale (MADRS) Rating lies on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5). Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Depression severity (change in score)
Time frame: Day 1, post-treatment point of 1 month
Depression severity as assessed by: 3. Beck Depression Inventory-II (BDI-II) Rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.
12 secondary outcomes
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time frame: Day 1, post-treatment point of 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Depression and Anxiety, run by Medical University of South Carolina 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 3 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Depression severity (change in score) (time frame: Day 1, post-treatment point of 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.