- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02754375
SMTr-METAB : FDG-PET Assessment of Cerebral Metabolism in Resistant Depression Treated With rTMS (SMTr-METAB)
Cerebral Functional Modifications After Low Frequency Repetitive Transcranial Magnetic Stimulation in Refractory Depression. Assessment With 18F-FDG-PET Imaging.
Studie Overzicht
Gedetailleerde beschrijving
In France, lifetime prevalence of depression is 21 %, with major consequences: handicap, loss of productivity, reduction in quality of life, increased mortality. The efficient and long-lasting care of depression is consequently a priority of public health.
Despite well-conducted conventional therapeutic strategies, it is estimated that about 30 % of the depressed patients do not respond at all to an antidepressant, that 30 % will present a partial response, and that 40 % only patients will have a complete remission.
Non-pharmacological alternative treatments have been promoted, particularly with repetitive transcranial magnetic stimulation (rTMS). A recent meta-analysis with 29 randomized controlled trials versus placebo reports a 29.3 % response rate and a 18.6 % remission rate after active stimulation vs respectively, 10.4 % and 5 % after placebo stimulation.
However, predictive biomarkers of response are unknown, and cerebral metabolism may be a good candidate. It is admitted that the depressive state is correlated with specific modifications of glucose metabolism in circuits which are involved in the neurobiology of depression. The amplitude of these changes may correlate with clinical severity or may differ with treatment type, and cerebral metabolic changes might be an additional guide to treatment. Finally, the therapeutic effect might normalize cerebral functional activity and this might be an early correlate of clinical response. However the studies using functional imaging in a therapeutic approach or in the understanding of the physiopathology of the depression are not usable in a clinical practice of routine.
The investigators suggest using a well-known analysis software (Scenium software, Siemens GmbH) who allows an automated analysis by the distribution of the cerebral metabolism by means of the F18-FDG TEP-TDM and a quantitative measure, expressed in regional consumption of glucose expressed by g / 100 g / min for every 18F-FDG TEP-TDM and for every region of interest. Image registering by the camera, remote of the injection of the tracer, lasts less than 10 minutes.The software also allows to compare the data acquired for a patient with a standardized database.
The investigators will perform a opened study in two centers (Monaco Hospital/Nice CHU) on 50 depressed patients aged from 40 to 65 years old, not having answered 2 lines of well led antidepressants. Low-frequency rTMS will be proposed in acute cure (3 in 6 weeks) in monotherapy followed by 6 months of rTMS for patients who have responded to acute treatment phase.
Cerebral metabolic modifications (location and intensity) will be calculated after two PET-TDM in every patient, realized before and after the acute treatment by rTMS. We shall use the SCENIUM software which allows to compare each patient's data with a standardized database.
At the end of the acute period of treatment, it will be proposed to patients who have responded to pursue rTMS treatment in a consolidation phase for 6 months. All patients will be longitudinally assessed during this consolidation period. One objective is to assess if initial TEP-TDM data and/or the amplitude of the induced metabolic variation is associated with the stability of the clinical answer in respondent patients
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Subject from 40 to 65 years old
- Characterized current depressive Episode, unipolar, without psychotic characteristic (according to DSM IV-TR)
- Presenting to the inclusion a score upper or equal to 20 on the scale HDRS-17
- Absence of answer or partial clinical answer to more than two antidepressant treatments of different therapeutic classes to effective posology on a duration of at least 6 weeks
- Patient affiliated to French social security
- Patient must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations
Exclusion Criteria:
- Failure in a previous low-frequency rTMS cure (at least 15 sessions)
- Failure in a cure of bilateral ECT (at least 8 sessions) or unilateral (at least 10 sessions)
- Mental disorder owed to a general medical affection ( DSM-IV)
- Presence of a neurodegenerative pathology in the inclusion estimated on the clinical examination, the intellectual MRI, the TEP / TDM at the 18F-FDG and the neuropsychological profile in the inclusion
- Severe or not stabilized somatic Disease
- chronic depression evolving for more than 3 years
- Not answer in more of therapeutic antidepressive five well (documented) conducts
- Presence of contraindication the SMTr, of which epileptic disease
- Schizophrenic Disorder
- Addicting Disorder with current dependence (alcohol, cannabis, benzodiazepin)
- Bipolar disorder (I, II)
- Disorder of personality to cluster A and B co-morbid
- Pregnant Woman (dosage of urinary Beta-HCG)
- Vulnerable Person: major under guardianship or guardianship, minor
- Mental Deficiency of the subject making its participation on approval impossible
- Participation in another clinical trial
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Patient
Patient with resistant depression treated with rTMS
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Variation of the regional cerebral glucose consumption between the two PET-TDM
Tijdsspanne: at week 6
|
Variation of the regional cerebral glucose consumption between the two PET-TDM (realized at inclusion and at Week 6)
|
at week 6
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Comparison of local glucose use between responder and non-responder patients
Tijdsspanne: at week 6
|
at week 6
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 15-PP-02
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op rTMS
-
Chang Gung Memorial HospitalWerving
-
Bayside HealthVoltooidAutistische stoornis | De stoornis van AspergerAustralië
-
Changping LaboratoryBeijing HuiLongGuan HospitalWervingErnstige depressieve stoornis | Ernstige depressie | Matige depressieChina
-
National Taiwan University Hospital Hsin-Chu BranchNog niet aan het werven
-
Assiut UniversityVoltooidObsessieve-compulsieve stoornissen
-
Centre hospitalier de Ville-Evrard, FranceWervingOm de effectiviteit van Open rTMS te evaluerenFrankrijk
-
Butler HospitalVoltooidObsessief-compulsieve stoornisVerenigde Staten
-
VA Office of Research and DevelopmentVoltooidTraumatische hersenschadeVerenigde Staten
-
Centre Hospitalier EsquirolVoltooid
-
University Hospital, RouenBeëindigd