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NCT02754375: SMTr-METAB
SMTr-METAB : FDG-PET Assessment of Cerebral Metabolism in Resistant Depression Treated With rTMS
NA trial testing rTMS in Depression in 22 participants. Completed in 20 March 2020.
6 February 2020
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Nice |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 22 |
| Start date | 4 May 2016 |
| Primary completion | 6 February 2020 |
| Estimated completion | 20 March 2020 |
| Sites | 2 locations across France, Monaco |
Drugs / interventions tested
- rTMS
Conditions studied
- Depression — all drugs for Depression →
Sponsor
Centre Hospitalier Universitaire de Nice
Who can join
Adults 40 to 65, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Biological markers of depressive states have been studied, but their usefulness to predict the therapeutic response is unknown. This issue is major in all depressive states which have not remitted after several lines of treatment. rTMS (repetitive transcranial magnetic stimulation) is a non-pharmacological alternative in the treatment of depression, but its effects on cerebral functioning are not known in episodes which have resist to conventional treatments. The investigators will include 50 depressive patients who have failed to respond to two successive antidepressant medication, and propose them a treatment with low frequency rTMS during 3 to 6 weeks. Cerebral functional imaging with 18FDG-PET (positon emission tomography) with be assessed at the beginning and at the end of rTMS acute treatment, in order to measure induced metabolic changes and their correlation with clinical states. Patients who have responded to rTMS acute treatment may continue this therapeutic for six months, and the investigators will assess if efficacy maintenance is related with cerebral metabolic variations
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 NCT02754375
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Centre Hospitalier Universitaire de Nice 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 NCT02754375 (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 Centre Hospitalier Universitaire de Nice
- Last refreshed: 18 April 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/NCT02754375.
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