Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment (Endo-rTMS)

February 13, 2024 updated by: Centre Hospitalier Rouffach

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Conduct of research :

This is a monocentric, non-randomized, open-label pilot study involving 50 male and female patients aged 18 to 65, hospitalized for major depression and presenting with an indication for treatment with repeated theta-burst transcranial magnetic stimulation (rTMS-TBS), i.e. a situation of therapeutic failure following 2 well-conducted antidepressant treatments.

At the end of the 20 rTMS-TBS sessions (one session per day, except weekends), the clinical response will be assessed by an investigator "blind" to the endocrine results. This response will be analyzed according to the status of neuroendocrine tests at inclusion (TRH-∆∆TSH and DST) and at the end of the study (for those who had one or more abnormal tests at inclusion and in whom the same tests were repeated at the end of the rTMS-TBS sessions).

During the inclusion visit, the patient and investigator sign the consent form, after double-checking the inclusion and non-inclusion criteria.

Immediately after the tenth rTMS session, an assessment of depression using the HAMD (17-item Hamilton Depression Scale) scale will be carried out by an independent psychiatrist, blind to the results of the neuroendocrine tests. This psychiatrist, who has already administered the HAMD at V0, will repeat the assessments at V1 and V2.

Immediately after the twentieth rTMS session, an assessment of depression using the HAMD scale will be carried out by an independent psychiatrist. This assessment will determine responder/non-responder status to rTMS-TBS.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Alsace
      • Rouffach, Alsace, France, 68250
        • Recruiting
        • Centre Hospitalier Rouffach
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Roberta Carcangiu, MD
        • Sub-Investigator:
          • Thomas Weiss, MD
        • Sub-Investigator:
          • Alexis Erb, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment resistant major depressed inpatients (TRDs)
Procedure: Repetitive transcranial magnetic stimulation (rTMS)
The theta burst stimulation (TBS) technique consists in administering bursts of transcranial magnetic stimulation (TMS) at very high frequency (50Hz) for 5 minutes (3 pulses of stimulation given at 50 hz; 10 bursts/1 s train; inter-train interval : 8 s; number of trains : 30; 100% resting motor threshold; number pulses/session : 900). Total number of sessions : 20 sessions (single daily session).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
17-item Hamilton Depression Scale (HAMD)
Time Frame: Change from inclusion result at 6 weeks (after 20 rTMS-TBS sessions)
Clinical response will be defined by at least a 50% decrease in depression score at the end of the 20 rTMS-TBS sessions - measured by the 17-item Hamilton Depression Scale (HAMD) - compared to inclusion (Carrozzino et al, 2020). The predictive value of the TRH-∆∆TSH on the one hand, and the DST on the other, will be assessed using an ROC curve and its AUC (Area Under the Curve) calculation.
Change from inclusion result at 6 weeks (after 20 rTMS-TBS sessions)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Scale (HAMD)
Time Frame: Through study completion, an average of 6 weeks
Functional remission will be defined by a HAMD score ≤ 8 at the end of 20 sessions of rTMS-TBS
Through study completion, an average of 6 weeks
Evolution of neuroendocrine parameters
Time Frame: Through study completion, an average of 6 weeks
Pre- and post-treatment difference in neuroendocrine test values
Through study completion, an average of 6 weeks
Evolution of neuroendocrine parameters
Time Frame: Through study completion, an average of 6 weeks
Proportion of patients having normalized their tests at the end of the 20 sessions of rTMs.
Through study completion, an average of 6 weeks
Relationship of the therapeutic response with the evolution of neuroendocrine parameters
Time Frame: Through study completion, an average of 6 weeks
Proportion of responders/functional remission patients according to the normalization or not of neuroendocrine tests after rTMS-TBS treatment.
Through study completion, an average of 6 weeks
Predictive factors
Time Frame: Through study completion, an average of 6 weeks
Predictors of response to rTMS treatment (e.g., demographics)
Through study completion, an average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Rouffach

Investigators

  • Principal Investigator: MIHAELA TOMSA, PhD, CENTRE HOSPITALIER DE ROUFFACH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A00288-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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