Clinical trial · Interventional
Practical Application of Accelerated iTBS for MDD
Practical Clinical Application of Accelerated Intermittent Theta Burst Stimulation for Major Depressive Disorder
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to evaluate the feasibility and efficacy of accelerated iTBS in adults diagnosed with Major Depressive Disorder. The main question it aims to answer is: What is the efficacy and tolerability of an accelerated iTBS regimen without radiological imaging in adults who have been diagnosed with Major Depressive Disorder and experience treatment resistant symptoms? Participants will complete 36 iTBS treatments in an accelerated schedule over five days. They will also complete several clinical assessments throughout their enrollment to evaluate their depressive symptoms and response to treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Major Depressive Disorder | — | UNRESOLVED | — |
| Major Depressive Disorder, Recurrent Episode, Severe | — | UNRESOLVED | — |
| Major Depressive Disorder, Recurrent, Moderate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NeuroStar TMS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Scheduled Treatment Arm
- description
- 5 day treatment course, 36 total treatments and clinical assessments.
- interventionNames
- Device: NeuroStar TMS
Primary outcomes (1)
- measure
- Montgomery-Asberg Depression Rating Scale
- timeFrame
- Baseline to four weeks post-treatment
- description
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) score, Minimum value = 0, Maximum value = 60. Higher score indicates a worse outcome.
Secondary outcomes (3)
- measure
- Patient Health Questionnaire
- timeFrame
- Baseline to four weeks post-treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female * 22- 70 years * Able to provide informed consent * Diagnosed with major depressive disorder (MDD) and currently experiencing a major depressive episode (MDE) * Subject failed to respond to at least one prior antidepressant medication * Subject consented to receive TMS therapy to treat MDD with his or her physician independent of potential participation in this clinical study Exclusion Criteria: * Subject satisfies any one or more of the contraindications for TMS therapy per current treatment guidelines as determined by the PI * Female with known or suspected pregnancy or is currently breastfeeding * Total MADRS score of \<20 at the screening or baseline visit * Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-V-TR), with the exception of nicotine dependence * History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes * Any disorder which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening * Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results * Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation * 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 * Current use of opiates * History of epilepsy * History of shrapnel or metal in the head or skull * History of cardiac event(s) * History of OCD * History of autism spectrum disorder * History of rTMS exposure within 6 months of initial study treatment
References
Publications (0)
Data not yet available