Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02754375 |
| Other study ID # |
15-PP-02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 4, 2016 |
| Est. completion date |
March 20, 2020 |
Study information
| Verified date |
April 2022 |
| Source |
Centre Hospitalier Universitaire de Nice |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
Description:
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
