N/A
N=40
Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study
Treatment Resistant Depression
Bottom Line
View on ClinicalTrials.gov: NCT03680781 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Change in Hamilton Depression Rating Scale 21-Item Score — 23.51; 9.44 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intermittent theta-burst stimulation (iTBS) delivered to the L-DLPFC (Device); Intermittent theta-burst stimulation (iTBS) delivered to the bilateral DLPFC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Depression Rating Scale 21-Item Score |
23.51; 9.44 | — |
| SECONDARY Change in Hamilton Rating Scale for Depression (HAMD-17) |
22.46; 8.04; 6.58; 8.94 | — |
| SECONDARY Change in The Scale for Suicide Ideation |
3.88; 1.46; 0.77; 0.38 | — |
| SECONDARY Change in Hamilton Rating Scale for Depression (HAMD-6) |
12.29; 9.48; 8.20; 7.50; 5.68 | — |
| SECONDARY Change From Baseline Functional Connectivity |
— | — |
| SECONDARY Change in Beck Depression Inventory (BDI) |
27.43; 11.39; 10.15 | — |
| SECONDARY Change in Montgomery-Åsberg Depression Rating Scale (MADRS) |
30.54; 10.72; 12.65 | — |
Summary
This study evaluates the effectiveness of re-treatment using accelerated schedule of intermittent theta-burst stimulation for treatment-resistant depression. This is an open label study.
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 to 75 years of age.
- Able to provide informed consent.
- Diagnosed with Major Depressive Disorder (MDD) or bipolar affective disorder 2 and currently experiencing a Major Depressive Episode (MDE).
- prior exposure to rTMS
- Participants must qualify as "moderate or severe treatment refractory" using the Maudsley staging method.
- Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. They must maintain that same antidepressant regimen throughout the study duration.
- Participants are required to have a stable psychiatrist for the duration of study enrollment.
Exclusion Criteria
- History of MI, CABG, CHF, or other cardiac history
- Any neurological conditions
- History of epilepsy
- OCD
- Independent sleep disorder
- Autism Spectrum Disorder
Data sourced from ClinicalTrials.gov (NCT03680781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.