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NCT Number: NCT04956016

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

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.

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Key information

Conditions

Depressive Disorder, Treatment-Resistant Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Henri Laborit

Poitiers, France

Location status: Recruiting

Location contact

Ghina Harika-Germaneau, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

classic rTMS using the 8-shaped coil

Device

20 rTMS sessions are planned (5 sessions per week)

deep rTMS using the H1-shaped coil

Device

20 rTMS sessions are planned (5 sessions per week)

Primary outcomes

  1. A 50% change of MADRS score

    Time frame: Day 60

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghina HARIKA-GERMANEAU, Dr

CONTACT

[email protected]

0033 5 16 52 61 18

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Laborit

Other

Registry information

Official study 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

Acronym: HAUVERDEEP

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2021
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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