Major Depressive Disorder Clinical Trial
Official title:
Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
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.
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). ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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