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NCT04138680: Biofeedback
Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression
NA trial testing Active Biofeedback in Major Depressive Disorder in 79 participants. Completed in 11 June 2024.
11 June 2024
Quick facts
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 79 |
| Start date | 9 October 2019 |
| Primary completion | 11 June 2024 |
| Estimated completion | 11 June 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Active Biofeedback
- Sham Biofeedback
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Icahn School of Medicine at Mount Sinai
Who can join
Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Previous research has shown that modulation of a brain region in rodents, the ventral tegmental area (VTA), improves depressive symptoms. Human research has also shown that VTA self-modulation using 'biofeedback' is feasible and successful in healthy volunteers. This biofeedback procedure is a type of cognitive training that includes real-time feedback about brain signal levels from the VTA. Our question is whether VTA self-modulation with biofeedback can influence depression symptoms.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04138680
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Icahn School of Medicine at Mount Sinai trials
Trials by the same sponsor.
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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 NCT04138680 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai
- Last refreshed: 4 September 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/NCT04138680.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing