Evaluating neuroendocrine tests to predict response to rTMS in major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to assess the predictive value of neuroendocrine tests, specifically the TRH-∆∆TSH and DST, in determining the response to repetitive transcranial magnetic stimulation with theta burst stimulation (rTMS-TBS) in patients with major depression. It involves 50 hospitalized patients aged 18 to 65 who have not responded adequately to two prior antidepressant treatments. The study will measure clinical response through the Hamilton Depression Scale after 20 sessions of rTMS-TBS, with assessments conducted by an independent psychiatrist who is blind to the neuroendocrine test results. The goal is to analyze how these tests correlate with treatment outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre Hospitalier Rouffach
  Rouffach, Alsace, France Recruiting

Study contacts

• Principal investigator: MIHAELA TOMSA, PhD — Centre Hospitalier de Rouffach
• Study coordinator: Mihaela Tomsa
• Email: m.tomsa@ch-rouffach.fr
• Phone: +33 389787018

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.