Evaluating neuroendocrine tests to predict response to rTMS in major depression
Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment : a Pilot Study in Major Depression (Endo-rTMS)
This study is trying to see if certain hormone tests can help predict how well a new brain stimulation treatment will work for people with major depression who haven't responded to other medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Rouffach Academic / other |
| Locations | 1 site (Rouffach, Alsace) |
| Trial ID | NCT05964192 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with major depression who have not responded to two previous antidepressant treatments.
Not a fit: Patients with endocrinopathy or contraindications to rTMS or neuroendocrine testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who are more likely to benefit from rTMS treatment, leading to improved management of major depression.
How similar studies have performed: While the use of rTMS has been studied, the specific combination of neuroendocrine testing with rTMS-TBS is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rouffach, Alsace
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.