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NCT03653858: FORESEE III
Efficacy Study of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression
NA trial testing Vercise GEVIA deep brain stimulation (DBS) system in Treatment-resistant Depression in 47 participants. Status unknown.
2 June 2025
Quick facts
| Lead sponsor | University Hospital Freiburg |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 3 September 2018 |
| Primary completion | 2 June 2025 |
| Estimated completion | 2 June 2025 |
| Sites | 2 locations across France, Germany |
Drugs / interventions tested
- Vercise GEVIA deep brain stimulation (DBS) system
Conditions studied
- Treatment-resistant Depression — all drugs for Treatment-resistant Depression →
Sponsor
University Hospital Freiburg
Who can join
Adults 20 to 75, any sex, with Treatment-resistant Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this multicenter, randomized, sham-controlled, double blind (patient and observer blinded) clinical trial is to assess the antidepressant effect of Deep Brain Stimulation (DBS) in patients with treatment resistant major depression using the Boston Scientific implantable Vercise™ GEVIA™ DBS system compared to sham.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991 -
"The Heart Asks Pleasure First"-Conceptualizing Psychiatric Diseases as <i>MAINTENANCE</i> Network Dysfunctions through Insights from slMFB DBS in Depression and Obsessive-Compulsive Disorder.
Coenen VA, Schlaepfer TE, Sajonz BEA, Reinacher PC, et al · · 2022 · cited 12× · PMID 35447971 · DOI 10.3390/brainsci12040438 -
A narrative review on invasive brain stimulation for treatment-resistant depression.
Dandekar MP, Diaz AP, Rahman Z, Silva RH, et al · · 2022 · cited 7× · PMID 34468549 · DOI 10.1590/1516-4446-2021-1874 -
Normalized affective responsiveness following deep brain stimulation of the medial forebrain bundle in depression.
Kilian HM, Schiller B, Meyer-Doll DM, Heinrichs M, et al · · 2024 · cited 4× · PMID 38191528 · DOI 10.1038/s41398-023-02712-y -
Joint Anatomical, Histological, and Imaging Investigation of the Midbrain Target Region for Superolateral Medial Forebrain Bundle Deep Brain Stimulation.
Coenen VA, Zielinski JM, Sajonz BEA, Reinacher PC, et al · · 2025 · cited 2× · PMID 39527932 · DOI 10.1159/000541834 -
ACNP 58<sup>th</sup> Annual Meeting: Poster Session III.
· 2019 · cited 2× · PMID 31801974 · DOI 10.1038/s41386-019-0547-9 -
Best practices for clinical trials of deep brain stimulation for neuropsychiatric indications.
Tremblay-McGaw AG, Hamlat EJ, Becker NC, Astudillo Maya DA, et al · · 2025 · cited 1× · PMID 40309667 · DOI 10.3389/fnhum.2025.1572972
Verify or expand the search:
- PubMed search for NCT03653858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT04680910 — Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) I · Phase 1 · active not recruiting
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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 NCT03653858 (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 Hospital Freiburg
- Last refreshed: 3 November 2022
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/NCT03653858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing