SMTr-METAB : FDG-PET Assessment of Cerebral Metabolism in Resistant Depression Treated With rTMS

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Apr 25, 2016

Keywords

ClinConnect Summary

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, particular...

Gender

ALL

Eligibility criteria

• 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