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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 April 2022
• Main ID: NCT02754375
• Date of registration: 21/04/2016
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nice
• Public title: SMTr-METAB : FDG-PET Assessment of Cerebral Metabolism in Resistant Depression Treated With rTMS SMTr-METAB
• Scientific title: Cerebral Functional Modifications After Low Frequency Repetitive Transcranial Magnetic Stimulation in Refractory Depression. Assessment With 18F-FDG-PET Imaging.
• Date of first enrolment: May 4, 2016
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02754375
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France, Monaco

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Procedure: rTMS

Primary Outcome(s)

Variation of the regional cerebral glucose consumption between the two PET-TDM [Time Frame: at week 6]

Secondary Outcome(s)

Comparison of local glucose use between responder and non-responder patients [Time Frame: at week 6]

Secondary ID(s)

15-PP-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors