Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study

Major Depressive Disorder Clinical Trial

— TMS/DEP  

Official title:

Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02383693
• Other study ID #: 2007-A00244-49
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 24, 2015
• Last updated: March 3, 2015
• Start date: January 2007
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Centre hospitalier de Ville-Evrard, France
• Contact: Dominique januel, MD.Phd
• Phone: 0143093232
• Email: domjanuel[@]gmail.com
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

number of center : 1

• duration of study : 24 months

• recruitement time : 23 months

• Aim :Principal

Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients.

Secondary

Evaluate the impact of rTMS on cognitive functions.

Description:

The study involves 40 TRD patients in a single site trial which consisted of two phases: an acute phase (phase I) in which all the participants receive active high-frequency stimulation during 4 blocks of five consecutive working days (Monday to Friday) in an open-label design and a maintenance phase (phase II) in which responders (> 49% HDRS-17 reduction from baseline) at the end of the phase I are randomized in two arms with sham or active high-frequency rTMS maintenance treatment for the eleven following months. The rhythm of rTMS sessions in this maintenance phase is gradually reduced as follows: 3 sessions per week for 2 weeks, 2 session per week for the 2 following weeks, 1 session per week the third (M3) and fourth month (M4) and then 1 session every fortnight the last eight months (M5 to M12).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• TRD stage I Thase-Rush

• HDRS + or = 18

• Patients age 18 to 70 years.

• Negative pregnancy test and contraception for women.

• Informed Consent

Exclusion Criteria:

• Patient was treated with mood stabilizer in the previous week

• Other disorder on axis I of the DSM IV than depressive disorder.

• Patient with an addiction problem other than tobacco and caféine

• antécedent of Epilepsy ,other neurological pathology and intra cranial metal diapositive or pacemaker

• Previous history of head trauma the previous two years.

• intracranial hypertension.

• not affiliated to the social security Patient

• patient under constraint hospitalisation

• Under legal protection measure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
France	Unité de Recherche Clinique	Neuilly Sur Marne	Île de France

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de Ville-Evrard, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	'Hamilton depression rating scale (HDRS)	The efficacy variables included the HDRS-17 item scores, the CGI changes, the Visual Analog Scale (VAS), the Beck Depression Inventory (BDI) and the Hospital Anxiety Depression (HAD).; The subjective assessment performed with the VAS consisted of a 100-mm horizontal line oriented with anchors placed at both poles for reassured, sadness, anxiety, and relief. The patients are asked to mark a spot along this line that best indicated the magnitude of their state for each item.	one years	No