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

Depressive Disorder, Treatment-Resistant Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956016
• Other study ID #: 2021-A00796-35
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: November 2024

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Henri Laborit
• Contact: Ghina HARIKA-GERMANEAU, Dr
• Phone: 0033 5 16 52 61 18
• Email: ghina.harika-germaneau[@]ch-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Intervention

Device:
• classic rTMS using the 8-shaped coil
20 rTMS sessions are planned (5 sessions per week)
• deep rTMS using the H1-shaped coil
20 rTMS sessions are planned (5 sessions per week)

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Laborit	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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