NCT02383693

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Centre hospitalier de Ville-Evrard, France · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Repetitive Transcranial Magnetic Stimulation	Repetitive Transcranial Magnetic Stimulation

Timeline

• Start date: 2007-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-03-09
• Last updated: 2015-03-09

Locations

1 site across 1 country: France