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Search / Trial NCT05964192

Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment

Launched by CENTRE HOSPITALIER ROUFFACH · Jul 26, 2023

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Depression Clinical Outcome R Tms (Repetitive Transcranial Magnetic Stimulation) Theta Burst Trh (Thyreoliberin) Test Dst (Dexamethasone Suppression Test)

ClinConnect Summary

This clinical trial is exploring how certain tests that measure hormone levels in the body can help predict how well patients with major depression will respond to a specific treatment called repetitive transcranial magnetic stimulation (rTMS). This treatment is non-invasive and aims to reduce depression symptoms. The researchers want to see if two specific tests—one that checks how the thyroid gland is functioning and another that evaluates how the body reacts to a steroid—can indicate whether a patient will experience at least a 50% improvement in their depression after undergoing 20 sessions of rTMS.

To participate in this study, individuals must be between 18 and 65 years old, have been diagnosed with a depressive episode, and have not responded well to two previous antidepressant treatments. It's important that they are willing to give written consent to join the study. However, certain individuals, such as those with specific health conditions or who are pregnant, are not eligible to participate. If eligible, participants can expect to receive the rTMS treatment and undergo the neuroendocrine tests, contributing important information that may help improve future depression treatments.

Gender

ALL

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.

About Centre Hospitalier Rouffach

Centre Hospitalier Rouffach is a reputable healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. With a focus on multidisciplinary collaboration, the center leverages its experienced staff and state-of-the-art facilities to conduct high-quality research across various therapeutic areas. Committed to ethical practices and patient safety, Centre Hospitalier Rouffach aims to contribute valuable insights to the medical community while fostering a supportive environment for participants throughout the trial process.

Locations

Rouffach, Alsace, France

Patients applied

0 patients applied

Trial Officials

MIHAELA TOMSA, PhD

Principal Investigator

CENTRE HOSPITALIER DE ROUFFACH

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported