Major Depressive DisorderiTBSNCT02506127
Intermittent Theta Burst Stimulation for MDD
A study testing Neuronetics XPLOR system in people with Major Depressive Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of intermittent Theta Burst Stimulation for patients with Major Depressive Disorder. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Neuronetics XPLOR system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2017to 8 Dec 2027
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with non-psychotic, unipolar Major Depressive Disorder (MDD) assessed via the MINI structured interview
- Must have been on a stable dose of antidepressant medication (excluding tricyclic antidepressants) for at least 1 month prior to randomization, and with significant residual MDD symptoms as evidenced by a HamD17 score > 17;
- If receiving medication other than for depression (e.g., anxiety, sleep, mood stabilization), must have been on stable dose for at least 1 month prior to randomization
- A history of treatment failure with at least one adequate trial of an antidepressant medication in the current episode, assessed by the Antidepressant Treatment and History Form
- Age range: 22-65.
Who cannot join
- Patient is mentally or legally incapacitated, unable to give informed consent.
- Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); current Mini Mental State Examination ≤ 24; delirium or substance abuse within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
- Patients with a HamD suicidality item score of '3' or '4,' corresponding to "suicidal ideas or gestures" or "attempts at suicide," will be excluded.
- Patients with exposure to Electroconvulsive Therapy within the past 6 months, previous TMS treatment for any condition, or Vagus Nerve Stimulation treatment (lifetime).
- Patients who have met diagnostic criteria for any current substance abuse disorder at any time in the 6 months prior to enrollment.
- Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, Cerebral Vascular Accident, or Transient Ischemic Attacks; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
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- Any history of intracranial implant including cochlear implant, implanted electrodes/stimulators, aneursym clips or coils, stents, bullet fragments; implanted cardiac pacemaker, defibrillator, vagus nerve stimulator, deep brain stimulator; or other implanted devices or objects contraindicated by product labeling.
- Neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or with primary or secondary tumors in the Central Nervous System.
- current pregnancy, breast feeding, or not using a medically accepted means of contraception.
- Infection or loss of integrity of skin over the forehead, where the device will be positioned.
- Increased risk of seizure as indicated by: a) history (or family history) of seizure or epilepsy; b) history of stroke, head injury, or unexplained seizures; c) concurrent medication use such as tricyclic antidepressants, neuroleptic medications, or other drugs that are known to lower the seizure threshold; d) secondary conditions that may significantly alter electrolyte balance or lower seizure threshold; e) no quantifiable motor threshold such that TMS dosage cannot be accurately determined.
- Other medical contraindications to any of the study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA TMS Clinic and Research Service
Los Angeles, California, 90025
About this study
Official title: A Sham-controlled Study of Prefrontal Intermittent Theta Burst Stimulation in Major Depressive Disorder
This study will evaluate the effectiveness of intermittent Theta Burst Stimulation for patients with Major Depressive Disorder.
Read the detailed description
The purpose of this research study is to evaluate the effectiveness and efficacy of intermittent Theta Burst Stimulation (iTBS) for treatment of Major Depressive Disorder (MDD). Subjects will be randomly assigned to two weeks (10 sessions) of treatment with open-label iTBS, blinded iTBS or blinded sham. 'Open-label' means that you (the subject) and the study staff will know that you are receiving active iTBS treatment. 'Blinded' or 'sham-controlled' means that you, the subject, will not know whether the treatment you receive is the active treatment or the non-active treatment. In the 'sham' condition, the stimulator will turn on but will not actually be stimulating your brain. Subjects who do not show remission of symptoms after the first 2 weeks of treatment will receive 10 additional treatment sessions with open-label active iTBS. Subjects will be evaluated at Week 12 to assess the durability of symptoms changes.
- Conditions
- Major Depressive Disorder
- Being tested
- Neuronetics XPLOR system
- Keywords
- TBS, MDD, Sham-controlled, neuromodulation, TMS
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuronetics XPLOR systemDevice
Transcranial magnetic stimulation system
| Study group | Role | What they receive |
|---|---|---|
| Open-label | Experimental | Theta burst stimulation (TBS) is a form of repetitive transcranial magnetic stimulation (TMS). Standard TBS parameters consisting of 3-pulse, 50Hz bursts every 200 ms (5 Hz) at an intensity of 80% motor threshold (MT) will be utilized. Intermittent TBS will be delivered in 2-second trains of bursts repeated every 10 seconds for a total of 570 seconds (1800 pulses) in each session.
Each treatment session thus involves < 10 minutes of stimulation. The subject and researchers know what treatment is being administered. Receives: Device: Neuronetics XPLOR system |
| Blinded Active | Active comparator | Standard TBS parameters consisting of 3-pulse, 50Hz bursts every 200 ms (5 Hz) at an intensity of 80% motor threshold (MT) will be utilized. Intermittent TBS will be delivered in 2-second trains of bursts repeated every 10 seconds for a total of 570 seconds (1800 pulses) in each session.
Each treatment session thus involves < 10 minutes of stimulation. The subject and researcher will not know what type of treatment will be administered. Receives: Device: Neuronetics XPLOR system |
| Blinded Sham | Sham comparator | This is a sham treatment which will mimic the open-label and blinded active to enable the effects of the supposedly "active" treatment to be assessed objectively. The subject and researcher will not know what type of treatment will be administered.
Each treatment session will be < 10 minutes in duration. Receives: Device: Neuronetics XPLOR system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Hamilton Depression Scale (HamD17)
Measured: two week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study start9 Dec 2017
- Primary completion8 Dec 2027 (estimated)
- Study completion8 Dec 2027 (estimated)
Why it stopped: Protocol discontinued for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew F. Leuchter, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506127
- Sponsor's protocol ID
- 15-000701
- Acronym
- iTBS
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2015
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sham-controlled Study of Prefrontal Intermittent Theta Burst Stimulation in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02506127
- Acronym / sponsor ID
- iTBS / 15-000701
- Conditions
- Major Depressive Disorder
- Keywords
- TBS, MDD, Sham-controlled, neuromodulation, TMS
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Protocol discontinued for futility
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 9 Dec 2017 (actual)
- Primary completion
- 8 Dec 2027 (estimated)
- Study completion
- 8 Dec 2027 (estimated)
- First posted
- 22 Jul 2015 (estimated)
- 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 will evaluate the effectiveness of intermittent Theta Burst Stimulation for patients with Major Depressive Disorder.
Detailed description
The purpose of this research study is to evaluate the effectiveness and efficacy of intermittent Theta Burst Stimulation (iTBS) for treatment of Major Depressive Disorder (MDD). Subjects will be randomly assigned to two weeks (10 sessions) of treatment with open-label iTBS, blinded iTBS or blinded sham. 'Open-label' means that you (the subject) and the study staff will know that you are receiving active iTBS treatment. 'Blinded' or 'sham-controlled' means that you, the subject, will not know whether the treatment you receive is the active treatment or the non-active treatment. In the 'sham' condition, the stimulator will turn on but will not actually be stimulating your brain. Subjects who do not show remission of symptoms after the first 2 weeks of treatment will receive 10 additional treatment sessions with open-label active iTBS. Subjects will be evaluated at Week 12 to assess the durability of symptoms changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open-label | Experimental | Device: Neuronetics XPLOR systemTheta burst stimulation (TBS) is a form of repetitive transcranial magnetic stimulation (TMS). Standard TBS parameters consisting of 3-pulse, 50Hz bursts every 200 ms (5 Hz) at an intensity of 80% motor threshold (MT) will be utilized. Intermittent TBS will be delivered in 2-second trains of bursts repeated every 10 seconds for a total of 570 seconds (1800 pulses) in each session. Each treatment session thus involves < 10 minutes of stimulation. The subject and researchers know what treatment is being administered. |
| Blinded Active | Active comparator | Device: Neuronetics XPLOR systemStandard TBS parameters consisting of 3-pulse, 50Hz bursts every 200 ms (5 Hz) at an intensity of 80% motor threshold (MT) will be utilized. Intermittent TBS will be delivered in 2-second trains of bursts repeated every 10 seconds for a total of 570 seconds (1800 pulses) in each session. Each treatment session thus involves < 10 minutes of stimulation. The subject and researcher will not know what type of treatment will be administered. |
| Blinded Sham | Sham comparator | Device: Neuronetics XPLOR systemThis is a sham treatment which will mimic the open-label and blinded active to enable the effects of the supposedly "active" treatment to be assessed objectively. The subject and researcher will not know what type of treatment will be administered. Each treatment session will be < 10 minutes in duration. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients with non-psychotic, unipolar Major Depressive Disorder (MDD) assessed via the MINI structured interview
- Must have been on a stable dose of antidepressant medication (excluding tricyclic antidepressants) for at least 1 month prior to randomization, and with significant residual MDD symptoms as evidenced by a HamD17 score > 17;
- If receiving medication other than for depression (e.g., anxiety, sleep, mood stabilization), must have been on stable dose for at least 1 month prior to randomization
- A history of treatment failure with at least one adequate trial of an antidepressant medication in the current episode, assessed by the Antidepressant Treatment and History Form
- Age range: 22-65.
Key exclusion criteria (12 listed)
- Patient is mentally or legally incapacitated, unable to give informed consent.
- Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); current Mini Mental State Examination ≤ 24; delirium or substance abuse within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
- Patients with a HamD suicidality item score of '3' or '4,' corresponding to "suicidal ideas or gestures" or "attempts at suicide," will be excluded.
- Patients with exposure to Electroconvulsive Therapy within the past 6 months, previous TMS treatment for any condition, or Vagus Nerve Stimulation treatment (lifetime).
- Patients who have met diagnostic criteria for any current substance abuse disorder at any time in the 6 months prior to enrollment.
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 |
|---|---|---|
| Neuronetics XPLOR systemTranscranial magnetic stimulation system | Device | Blinded Active, Blinded Sham, Open-label |
Primary outcome
Percent change in Hamilton Depression Scale (HamD17)
Time frame: two week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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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 Neuronetics XPLOR system in people with Major Depressive Disorder, run by University of California, Los Angeles 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 5 inclusion and 12 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: paused, as of the sponsor's last update on 16 Oct 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. 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?
Results are not available in the source record.
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?
Percent change in Hamilton Depression Scale (HamD17) (time frame: two week). 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 16 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.