Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-01-02 @ 2:39 AM
Study NCT ID:
NCT02383693
Status:
UNKNOWN
Last Update Posted:
2015-03-09
First Post:
2015-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
Sponsor:
Centre hospitalier de Ville-Evrard, France
Organization:
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:
TMS/DEP
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:
False
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?: