New treatment option for Major Depression
Official title Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment
ClinicalTrials.gov ID: NCT05964192
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- Patient with endocrinopathy ;
- 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,
See the full eligibility criteria
- 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.
- Patient with endocrinopathy ;
- 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;
- Patient previously treated with monoamine oxidase inhibitor (MAOI) antidepressant or lithium salts (within 6 months prior to inclusion);
- Pregnant or lactating patient;
- Patient under court protection or deprived of liberty;
- Patient under guardianship/guardianship.
The study team makes the final eligibility decision.
Where it's taking place
- Rouffach, Alsace, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rouffach, Alsace, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.