NCT05964192Recruiting
Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment
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)
Source: ClinicalTrials.gov · Last updated 14 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 17 Jul 2023
- Start date
- 1 Apr 2024
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Centre Hospitalier Rouffach
- Diseases
- Depression
- NCT number
- NCT05964192
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Apr 2024 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient previously treated with monoamine oxidase inhibitor (MAOI) antidepressant or lithium salts (within 6 months prior to inclusion);
Other illness
- 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;
Other
- Patient with endocrinopathy ;
- Pregnant or lactating patient;
- Patient under court protection or deprived of liberty;
- Patient under guardianship/guardianship.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Rouffach Coordinator of this site? Confirm its status | Rouffach | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.