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

Phase 2

• Conditions: Major Depressive Disorder
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT02383693
• Lead Sponsor: Centre hospitalier de Ville-Evrard, France

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2015-02-24
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-03
• Last Update Submitted: 2015-03-03
• Study First Posted: 2015-03-09
• Last Update Posted: 2015-03-09
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
repetitive transcranial magnetic stimulation	Repetitive Transcranial Magnetic Stimulation	Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks
Sham comparator	Repetitive Transcranial Magnetic Stimulation	Placebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks

Primary Outcome Measures

Name	Time	Method
'Hamilton depression rating scale (HDRS)	one years	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.

Trial Locations

Locations (1)

Unité de Recherche Clinique; 🇫🇷 Neuilly Sur Marne, Île de France, France