Last reviewed · How we verify
NCT01973478: STHYM
Deep Brain Stimulation in Patients With Chronic Treatment Resistant Depression
NA trial testing DBS in Major Depressive Disorder in 9 participants. Completed in 27 November 2018.
3 July 2017
Quick facts
| Lead sponsor | Rennes University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 3 June 2014 |
| Primary completion | 3 July 2017 |
| Estimated completion | 27 November 2018 |
| Sites | 5 locations across France |
Drugs / interventions tested
- DBS
- SHAM
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
- Recurrent Depressive Disorder — all drugs for Recurrent Depressive Disorder →
- Bipolar Disorder — all drugs for Bipolar Disorder →
Sponsor
Rennes University Hospital
Who can join
Adults 18 to 70, any sex, with Major Depressive Disorder or Recurrent Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Major depressive disorders are real public health issues in terms of diagnosis and treatment. Some forms of depression are chronic and resistant to treatment (TRD). In these forms suicide risk is important. Patients with TRD are potential candidates for neurosurgical interventions to treat depression. However, psychosurgery interventions based upon lesions, showed their limitations related to 1. the large variability in neurosurgical gestures, 2. their side effects, and of course 3. the irreversible damage caused by the surgery. Thus, deep brain stimulation (DBS) could represent an opportunity for patients suffering from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed encouraging results. The investigators have thus planned a randomized controlled trial versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.
Publications & conference data
1 peer-reviewed publication 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
Verify or expand the search:
- PubMed search for NCT01973478
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Major Depressive Disorder
Currently open trials in the same condition.
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- NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting
Other Rennes University Hospital trials
Trials by the same sponsor.
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- NCT06950398 — Normothermic Oxygenated Perfusion (NMP) Viability Testing Before Transplantation of Discarded Livers · Phase 2 · not yet recruiting
- NCT07188753 — Randomized Controlled Trial Testing the Efficacy of Transcranial Magnetic Stimulation by Accelerated & High-dose Theta-b · NA · not yet recruiting
- NCT06898099 — Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR) · NA · 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 NCT01973478 (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 Rennes University Hospital
- Last refreshed: 27 December 2019
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/NCT01973478.
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