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Clinical Trial NCT07329153 for Treatment Resistant Depression (TRD) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Neuronavigated aiTBS for TRD 247 Randomized Confirmatory Trial
Neuronavigated and Non-Neuronavigated Accelerated Intermittent Theta-Burst Stimulation for Treatment-Resistant Depression A Sham-Controlled Randomized Controlled Trial
- STU-2025-1926
TMS
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalNeuronavigated aiTBS TBS device placement during treatment determined by MRI imaging | aiTBS Repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation. |
Active ComparatorNon-Neuronavigated aiTBS Conventional device placement during treatment | aiTBS Repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation. |
Sham ComparatorSham aiTBS identical procedures as the other 2 groups but without turning on the device | aiTBS Repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
HDRS-17 - Depression severity assessment | depression severity as assessed by the Hamilton Depression Rating Scale-17 items (HDRS-17) | From Baseline visit until week 5 visit |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Montgomery-Åsberg Depression Rating Scale (MADRS) | From Baseline visit until week 5 visit. | |
Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) | participant self-rated symptomatology | From Baseline visit until week 5 visit |
Age: 18 to 65 years at the time of consent
Diagnosis: Current major depressive episode (MDE) in the context of unipolar major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by clinical psychiatric interview
Treatment Resistance: Documented failure to respond to at least two adequate antidepressant trials on the Antidepressant Treatment History Form-Short Form (ATHF-SF). An adequate trial is defined as:
- Antidepressant medication at the maximum tolerated dose for at least 6 weeks, OR
- Evidence-based psychotherapy consisting of at least 12 sessions
Depression Severity: Montgomery-Åsberg Depression Rating Scale (MADRS) score >19 at screening, indicating moderate to severe depression
Medication Stability: No changes in antidepressant medication type or dose for at least 6 weeks prior to randomization. Stable doses of permitted medications must be maintained throughout the trial
Informed Consent: Demonstrated capacity to provide written informed consent and comply with study procedures
Availability: Ability to attend treatment sessions for 15 consecutive workdays (approximately 90 minutes per day) and complete assessments including 4-hour evaluations at baseline and endpoint
Psychiatric Exclusions:
Any psychiatric disorder other than MDD and comorbid anxiety disorders, including but not limited to:
(i) Bipolar disorder (Type I or II) (ii) Schizophrenia spectrum or other psychotic disorders (iii) Post-traumatic stress disorder (PTSD) (iv) Attention-deficit/hyperactivity disorder (ADHD) (v) Autism spectrum disorder (ASD) (vi) Obsessive-compulsive disorder (OCD) (vii) Current DSM-5 substance-use disorder (abuse or dependence) within the past 6 months, except nicotine dependence
Personality disorder confirmed on clinical interview by an experienced study psychiatrist
Severe suicidal ideation with structured plan (HDRS-17 item 3 score >2) or as determined by the evaluating psychiatrist
Depressive symptoms better explained by another psychiatric condition, a medical condition, substance use, or use of medications
Medical and Neurological Exclusions:
Any neurological disorder including but not limited to:
(i) History of seizure disorder or epilepsy (ii) Family history of epilepsy (first-degree relatives) (iii) Significant head trauma with loss of consciousness >5 minutes (iv) Stroke or transient ischemic attack (v) Neurodegenerative disorders (e.g., Parkinson's disease, multiple sclerosis, dementia) (vi) Brain tumor or intracranial mass lesion
Unstable medical condition, defined as any condition requiring acute medical intervention or hospitalization within the past 3 months, or any condition that in the investigator's judgment could affect participant safety or study outcomes
Contraindications to TMS/MRI:
Presence of ferromagnetic material in or near the head, including:
(i) Intracranial implants (e.g., aneurysm clips, shunts, stimulators) (ii) Cochlear implants or hearing aids (iii) Metallic facial tattoos or permanent makeup (iv) Other implanted medical devices deemed unsafe for MRI/TMS
Inability to tolerate MRI scanning due to claustrophobia or other reasons
Medication Exclusions:
Current use of medications known to significantly alter cortical excitability:
- Anticonvulsants (including those used for mood stabilization)
- Psychostimulants
- Lithium
- Benzodiazepines exceeding 10mg diazepam-equivalent daily dose
Prior Treatment Exclusions:
- Electroconvulsive therapy (ECT) (≥ 6 sessions) in the current depressive episode
- Ketamine or esketamine treatment (≥ 6 sessions) in the current depressive episode
- Use of rTMS/iTBS (≥ 15 sessions) during the current depressive episode
- Vagus nerve stimulation (VNS) or deep brain stimulation (DBS) implantation
Psychotherapy:
• Concurrent evidence-based psychotherapy is permitted if initiated >4 weeks prior to enrollment and maintained at stable frequency throughout the tria
Other reasons:
- Unable to adhere to the study visit schedule
- Planning to relocate outside the study catchment area during the trial period
- No reliable transportation to attend study visits
- Current participation in another research study
- Current pregnancy (confirmed by in interview and clinical evaluation and, if deemed necessary, urine pregnancy test at screening)
- Currently breastfeeding
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