NCT05964192

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
38mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Apr 2024Jun 2029

First Submitted

Initial submission to the registry

July 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

February 14, 2024

Status Verified

July 1, 2023

Enrollment Period

4.4 years

First QC Date

July 17, 2023

Last Update Submit

February 13, 2024

Conditions

Major Depression

Keywords

Depressionclinical outcomerTMS (repetitive transcranial magnetic stimulation)theta burstTRH (thyreoliberin) testDST (dexamethasone suppression test)

Outcome Measures

Primary Outcomes (1)

  • 17-item Hamilton Depression Scale (HAMD)

    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 Outcomes (5)

  • Hamilton Depression Scale (HAMD)

    Through study completion, an average of 6 weeks

  • Evolution of neuroendocrine parameters

    Through study completion, an average of 6 weeks

  • Evolution of neuroendocrine parameters

    Through study completion, an average of 6 weeks

  • Relationship of the therapeutic response with the evolution of neuroendocrine parameters

    Through study completion, an average of 6 weeks

  • Predictive factors

    Through study completion, an average of 6 weeks

Study Arms (1)

Treatment resistant major depressed inpatients (TRDs)

EXPERIMENTAL
Procedure: Repetitive transcranial magnetic stimulation (rTMS)

Interventions

Repetitive transcranial magnetic stimulation (rTMS)PROCEDURE

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).

Treatment resistant major depressed inpatients (TRDs)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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;
  • Patient with written informed consent to participate in the study;
  • Patient enrolled in or receiving social security benefits.

You may not qualify 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,
  • intracranial hypertension,
  • poorly balanced comitiality,
  • in the case of well-balanced comitiality, a neurological consultation with electroencephalogram (EEG) is planned before including the patient;
  • Pregnant or lactating patient;
  • Patient under court protection or deprived of liberty;
  • Patient under guardianship/guardianship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Rouffach

Rouffach, Alsace, 68250, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • MIHAELA TOMSA, PhD

    CENTRE HOSPITALIER DE ROUFFACH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MIHAELA TOMSA

CONTACT

+33 389787018m.tomsa@ch-rouffach.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 27, 2023

Study Start

April 1, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

February 14, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)