Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment
Recruiting now · Not applicable
Conditions studied: Major Depression
In brief
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.
Key facts
- Study ID
- NCT05964192
- Run by
- Centre Hospitalier Rouffach
- People needed
- 50
- Starts
- 2024-04-01
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2024-02-14
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Centre Hospitalier Rouffach — Rouffach, Alsace, France (enrolling)
Full record on ClinicalTrials.gov
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