NCT04956016

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Aug 2021

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 Progress68%
Aug 2021Aug 2028

First Submitted

Initial submission to the registry

June 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 23, 2021

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6.9 years

First QC Date

June 29, 2021

Last Update Submit

January 12, 2026

Conditions

Depressive Disorder, Treatment-Resistant

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 60

Study Arms (2)

classic rTMS treatment

ACTIVE COMPARATOR

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

Device: classic rTMS using the 8-shaped coil

treatment with deep rTMS

ACTIVE COMPARATOR

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

Device: deep rTMS using the H1-shaped coil

Interventions

deep rTMS using the H1-shaped coilDEVICE

20 rTMS sessions are planned (5 sessions per week)

treatment with deep rTMS
classic rTMS using the 8-shaped coilDEVICE

20 rTMS sessions are planned (5 sessions per week)

classic rTMS treatment

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Henri Laborit

Poitiers, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Ghina HARIKA-GERMANEAU, Dr

    Centre Hospitalier Henri Laborit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghina HARIKA-GERMANEAU, Dr

CONTACT

0033 5 16 52 61 18ghina.harika-germaneau@ch-poitiers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 9, 2021

Study Start

August 23, 2021

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

FR(1)