Actively Recruiting
Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation Treatment: a Pilot Study in Major Depression
Led by Centre Hospitalier Rouffach · Updated on 2024-02-14
50
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the predictive value of specific neuroendocrine tests (TRH-ΔΔTSH and DST) in how patients with major depression respond to repetitive transcranial magnetic stimulation-theta burst stimulation (rTMS-TBS). This pilot study involves adults aged 18 to 65 who have major depression and have not adequately responded to two previous antidepressant treatments. The goal is to see if these tests can predict a decrease of at least 50% in depression scores after treatment. The study involves 20 sessions of rTMS-TBS delivered once daily on weekdays. This treatment uses bursts of magnetic stimulation at high frequency for about five minutes per session. Patients will be evaluated for their depression symptoms at baseline, after ten sessions, and after the full 20 sessions using the 17-item Hamilton Depression Scale. Neuroendocrine tests are performed at the start and, if abnormal initially, again at the end of the treatment. Participants will be hospitalized patients monitored by investigators who assess their depression levels while blinded to the neuroendocrine test results. Assessments occur at inclusion, mid-treatment, and end of treatment to determine response. The main outcome is the change in depression scores after six weeks. Safety and other neuroendocrine changes will also be observed. The study is conducted over about six weeks with careful clinical and laboratory monitoring throughout.
CONDITIONS
Brief Title
Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient diagnosed with a depressive episode according to DSM-5 criteria
- Age between 18 and 65 years
- Inpatient with inadequate response to two well-conducted antidepressant treatments
- Hamilton Depression Scale (HAMD-17) score at inclusion of 18 or higher
- Provided written informed consent to participate
- Enrolled in or receiving social security benefits
You will not qualify if you...
- Patient with endocrinopathy
- Contraindication to neuroendocrine testing (allergy to test substances or excipients)
- Contraindications to rTMS including cochlear implant, cardiac pacemaker, metal implants near stimulation coil, intracranial hypertension
- Poorly controlled epilepsy or requiring neurological evaluation if epilepsy is well-controlled
- Prior treatment with MAOI antidepressants or lithium salts within 6 months before inclusion
- Pregnant or breastfeeding patients
- Patients under court protection, deprived of liberty, or under guardianship
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive 20 sessions of repetitive transcranial magnetic stimulation (rTMS) treatment, with one session per day excluding weekends.
20 daily sessions (Monday to Friday)
Duration - During and immediately after treatment
Participants undergo depression assessments using the Hamilton Depression Scale at mid-treatment and at the end of treatment by an independent psychiatrist.
3 visits (at baseline, after 10 sessions, after 20 sessions)
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Rouffach
Rouffach, Alsace, France, 68250
Actively Recruiting
Research Team
M
MIHAELA TOMSA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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