Last reviewed · How we verify
NCT06003309: FREED
Frequency and E-field Enhancement of ITBS for Depression (FREED)
NA trial testing Transcranial Magnetic Stimulation (TMS) - Fully Individualized iTBS in Major Depressive Disorder in 75 participants. Completed in 30 December 2025.
30 December 2025
Quick facts
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 31 August 2023 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 2 locations across United States, Australia |
Drugs / interventions tested
- Transcranial Magnetic Stimulation (TMS) - Fully Individualized iTBS
- Transcranial Magnetic Stimulation (TMS) - targeted-iTBS
- Transcranial Magnetic Stimulation (TMS) - Standard-iTBS
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
University of California, San Diego
Who can join
Adults 18 to 80, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators propose a randomized 3-arm double-blinded parallel experimental trial (20 sessions over 4 weeks) in 75 patients with TRD. The three arms include (1) the combination of a fully Individualized form of intermittent Theta Burst Stimulation (iTBS) (using BOTH the frequency and electric field (E-field) targeting approaches) (Ind-iTBS)), (2) iTBS individualized using E-field targeting only (targeted-iTBS) and (3) Standard iTBS treatment (i.e., typical iTBS localized to the dorsolateral prefrontal cortex (DLPFC) using the Beam F3 method). Electroencephalography (EEG) data will be collected at rest and during a working memory task, at baseline, and at the end of treatment along with clinical assessments of depression severity. The target engagement dependent variable of interest in these three arms will be fronto-parietal theta connectivity measured through resting-state EEG. The investigators hypothesize that stimulation with Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity than that produced with targeted-TBS and standard iTBS. Aim: To evaluate the effects of two individualized forms of iTBS (i.e., using BOTH the frequency and E-field individualization; Ind-iTBS) compared to iTBS individualized for E-field targeting only (targeted-iTBS) and standard iTBS on fronto-parietal theta connectivity. Hypotheses: (1) Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity compared to both targeted-iTBS and standard iTBS. (2) Ind-iTBS will also lead to a greater reduction in depressive symptoms (as defined by the mean reduction in Montgomery Åsberg Depression Rating Scale Scores (MADRS)) compared to both targeted-iTBS and standard iTBS.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Stochastic Approximator of Motor Threshold (SAMT) for Transcranial Magnetic Stimulation: Online Software and Its Performance in Clinical Studies.
Wang B, Shah VU, Koponen LM, Neacsiu AD, et al · · 2026 · PMID 42226747 · DOI 10.1016/j.transm.2026.100312
Verify or expand the search:
- PubMed search for NCT06003309
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Major Depressive Disorder
Currently open trials in the same condition.
- NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
- NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
- NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
- NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
- NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting
Other University of California, San Diego trials
Trials by the same sponsor.
- NCT07342543 — Guided Physical Activity Counseling for Hypertension in Primary Care · NA · not yet recruiting
- NCT06505317 — Artificial Intelligence for Early Detection of Peripheral Artery Disease · NA · not yet recruiting
- NCT07211802 — CKM For Safe Use of SGLT2i in Type 1 Diabetes · Phase 3 · not yet recruiting
- NCT07524751 — Culturally Adapted Pain Management for Indigenous Peoples · NA · not yet recruiting
- NCT07518784 — Accurate Point of Care Liver Disease Diagnostics (Phase 2) · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06003309 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
- Last refreshed: 13 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06003309.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing