NCT05964192 Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment
| NCT ID | NCT05964192 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Rouffach |
| Condition | Major Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-04-01 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patient with a characterized depressive episode defined according to DSM-5 (diagnostic and statistical manual of mental disorders) criteria; 2. Patient between the ages of 18 and 65 years; 3. Inpatient with an inadequate response to two prior well-conducted antidepressant treatments (Hamilton 17-item scale \[HAMD-17\] score at inclusion≥ 18) ; 4. Patient with written informed consent to participate in the study; 5. Patient enrolled in or receiving social security benefits. Exclusion Criteria: 1. Patient with endocrinopathy ; 2. Patient with a contraindication to neuroendocrine testing (hypersensitivity to the active substance or to one of the excipients); 3. 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; 4. Patient previously treated with monoamine oxidase inhibitor (MAOI) antidepressant or lithium salts (within 6 months prior to inclusion); 5. Pregnant or lactating patient; 6. Patient under court protection or deprived of liberty; 7. Patient under guardianship/guardianship.
Contact & Investigator
MIHAELA TOMSA, PhD
PRINCIPAL INVESTIGATOR
CENTRE HOSPITALIER DE ROUFFACH
Frequently Asked Questions
Who can join the NCT05964192 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05964192 currently recruiting?
Yes, NCT05964192 is actively recruiting participants. Contact the research team at m.tomsa@ch-rouffach.fr for enrollment information.
Where is the NCT05964192 trial being conducted?
This trial is being conducted at Rouffach, France.
Who is sponsoring the NCT05964192 clinical trial?
NCT05964192 is sponsored by Centre Hospitalier Rouffach. The principal investigator is MIHAELA TOMSA, PhD at CENTRE HOSPITALIER DE ROUFFACH. The trial plans to enroll 50 participants.
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