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Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment (HAUVERDEEP)

Primary Purpose

Depressive Disorder, Treatment-Resistant

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

classic rTMS using the 8-shaped coil

deep rTMS using the H1-shaped coil

About this trial

This is an interventional treatment trial for Depressive Disorder, Treatment-Resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Volunteer subjects over 18 years old
Having signed a free and informed consent
Having a diagnostic of caracterised depressive episod recurrent or isolated according to DSM IV criteria (A.P.A 1994).
Having an antidepressant treatment not modified since 3 weeks
Score to MADRS scale ≥ 21
Subject affiliated to a social security regimen

Exclusion Criteria:

Depression with psychotic caracteristics
Co-morbid diagnosis according to axis I (DSM IV) of schizophrenia, dependence (or abuse) on alcohol and / or another substance (lifetime)
Patient who has already undergone seismotherapy for current episode and non-responder to this treatment
Patient hospitalized under duress or under legal protection (guardianship, curatorship)
Patient with a high risk of suicide (item 10 of MADRS > 4) in the absence of hospitalization.
Contra-indication for IRM exam or rTMS : personnal history of comitial crisis, of neurological or neurochirurgical pathologies, metallic prosthetic material or foreign body (pacemaker, intraoculare ferromagnetic material, implanted cardiac defibrillator, cochlear implant, metal clip
Pregnancy
Simultaneous participation to another interventionnal study

Sites / Locations

Centre Hospitalier Henri LaboritRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

classic rTMS treatment

treatment with deep rTMS

Arm Description

Arm A: classic rTMS treatment (use of the 8-shaped coil) and standard therapy

Arm B: treatment with deep rTMS (use of the H1-shaped coil (helmet)) and standard therapies

Outcomes

Primary Outcome Measures

A 50% change of MADRS score

The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. Modification of the MADRS score compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score >34 being severe depression.

Secondary Outcome Measures

Full Information

NCT ID

NCT04956016

First Posted

June 29, 2021

Last Updated

January 18, 2023

Sponsor

Centre Hospitalier Henri Laborit

1. Study Identification

Unique Protocol Identification Number

NCT04956016

Brief Title

Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment

Acronym

HAUVERDEEP

Official Title

Open-label Randomized Comparative Study of the Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment in the Management of Resistant Depression

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 23, 2021 (Actual)

Primary Completion Date

November 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Henri Laborit

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. The patient will receive treatment arm A or B : Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and standard therapies. 20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Treatment-Resistant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

classic rTMS treatment

Arm Type

Active Comparator

Arm Description

Arm A: classic rTMS treatment (use of the 8-shaped coil) and standard therapy

Arm Title

treatment with deep rTMS

Arm Type

Active Comparator

Arm Description

Arm B: treatment with deep rTMS (use of the H1-shaped coil (helmet)) and standard therapies

Intervention Type

Device

Intervention Name(s)

classic rTMS using the 8-shaped coil

Intervention Description

20 rTMS sessions are planned (5 sessions per week)

Intervention Type

Device

Intervention Name(s)

deep rTMS using the H1-shaped coil

Intervention Description

20 rTMS sessions are planned (5 sessions per week)

Primary Outcome Measure Information:

Title

A 50% change of MADRS score

Description

Time Frame

Day 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Volunteer subjects over 18 years old Having signed a free and informed consent Having a diagnostic of caracterised depressive episod recurrent or isolated according to DSM IV criteria (A.P.A 1994). Having an antidepressant treatment not modified since 3 weeks Score to MADRS scale ≥ 21 Subject affiliated to a social security regimen Exclusion Criteria: Depression with psychotic caracteristics Co-morbid diagnosis according to axis I (DSM IV) of schizophrenia, dependence (or abuse) on alcohol and / or another substance (lifetime) Patient who has already undergone seismotherapy for current episode and non-responder to this treatment Patient hospitalized under duress or under legal protection (guardianship, curatorship) Patient with a high risk of suicide (item 10 of MADRS > 4) in the absence of hospitalization. Contra-indication for IRM exam or rTMS : personnal history of comitial crisis, of neurological or neurochirurgical pathologies, metallic prosthetic material or foreign body (pacemaker, intraoculare ferromagnetic material, implanted cardiac defibrillator, cochlear implant, metal clip Pregnancy Simultaneous participation to another interventionnal study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ghina HARIKA-GERMANEAU, Dr

Phone

0033 5 16 52 61 18

ghina.harika-germaneau@ch-poitiers.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ghina HARIKA-GERMANEAU, Dr

Organizational Affiliation

Centre Hospitalier Henri Laborit

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Henri Laborit

City

Poitiers

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ghina Harika-Germaneau, MD, PhD

12. IPD Sharing Statement

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Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment

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