Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02383693
Status:
UNKNOWN
Last Update Posted:
2015-03-09
First Post:
2015-02-24
Brief Title:
Maintenance rTMS for Treatment-resistant Depression TRD a One-year Double Blind Controlled Study
Sponsor:
Centre hospitalier de Ville-Evrard France
Organization:
Centre hospitalier de Ville-Evrard France
Study Overview
Official Title:
Maintenance rTMS for Treatment-resistant Depression TRD a One-year Double Blind Controlled Study
Status:
UNKNOWN
Status Verified Date:
2015-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMSDEP
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None