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NCT05393648
Bipolar Efficacy Biomarkers for rTMS
NA trial testing Accelerated Theta Burst Stimulation in Bipolar Disorder in 60 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 5 July 2022 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Accelerated Theta Burst Stimulation
- Sham accelerated Theta Burst Stimulation
Conditions studied
- Bipolar Disorder — all drugs for Bipolar Disorder →
- Bipolar Depression — all drugs for Bipolar Depression →
Sponsor
University of California, San Diego
Who can join
Adults 18 to 70, any sex, with Bipolar Disorder or Bipolar Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of repetitive transcranial magnetic stimulation) produces a significant reduction in depressive symptoms compared with sham. This project will recruit patients aged 18-70 with symptoms of bipolar depression (BPD) who have failed (or not shown signs of improvement) after at least two prior treatments. The null hypothesis is that there will be no difference in reductions in depressive symptoms by the end of a five-day treatment period. The alternative hypothesis is that, compared with sham, active TMS will result in a greater reduction in depressive symptoms by the end of the treatment period. To facilitate the development of rTMS protocols there is a need for biomarkers that are sensitive to BPD symptom severity and clinical improvement. Previously in our lab, investigators developed biomarkers suitable for depression trials, and these biomarkers are very likely to show sensitivity to BPD, since they are associated with brain regions and functions associated with BPD. As a secondary aim, the investigators will try to identify biomarkers in cortical region associated with BPD, and formulate a statistical model that may be able to predict BPD remission after the treatment. this study will lead to development of new brain stimulation treatment protocols and biomarkers, will aid in treatment selection, and eventually lead to better clinical outcome for patients suffering from BPD.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Accelerated Intermittent Theta-Burst Stimulation for Treatment-Resistant Bipolar Depression: A Randomized Clinical Trial.
Appelbaum LG, Daniels H, Lochhead L, Bacio B, et al · · 2025 · cited 5× · PMID 39932714 · DOI 10.1001/jamanetworkopen.2024.59361
Verify or expand the search:
- PubMed search for NCT05393648
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05393648 (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: 4 March 2024
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/NCT05393648.
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