Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment
Recruiting · NCT05964192 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Rouffach
View the official record on ClinicalTrials.gov →Interventions studied
Repetitive transcranial magnetic stimulation (rTMS)
What this trial is about
The primary objective of the study is to determine the predictive value of the neuroendocrine tests TRH-∆∆TSH (thyreoliberin - thyreostimulin) and DST (dexamethasone suppression test) in the subsequent response to rTMS-TBS (repetitive transcranial magnetic stimulation-theta burst stimulation) treatment, defined as at least a 50% decrease in depression score after 20 sessions of rTMS-TBS.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patient with a characterized depressive episode defined according to DSM-5 (diagnostic and statistical manual of mental disorders) criteria;
- Patient between the ages of 18 and 65 years;
- Inpatient with an inadequate response to two prior well-conducted antidepressant treatments (Hamilton 17-item scale \[HAMD-17\] score at inclusion≥ 18) ;
- Patient with written informed consent to participate in the study;
- Patient enrolled in or receiving social security benefits.
Exclusion criteria
- Patient with endocrinopathy ;
- Patient with a contraindication to neuroendocrine testing (hypersensitivity to the active substance or to one of the excipients);
- Patient with a contraindication to rTMS:
- cochlear implant,
- cardiac pacemaker,
- metal clips, stents or other electronic implants within one meter of the stimulation coil,
- intracranial hypertension,
- poorly balanced comitiality,
- in the case of well-balanced comitiality, a neurological consultation with electroencephalogram (EEG) is planned before including the patient;
- Patient previously treated with monoamine oxidase inhibitor (MAOI) antidepressant or lithium salts (within 6 months prior to inclusion);
- Pregnant or lactating patient;
- Patient under court protection or deprived of liberty;
- Patient under guardianship/guardianship.
Where it is running
1 location listed.
- Centre Hospitalier Rouffach - Rouffach, Alsace, France