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

Sponsor

Centre hospitalier de Ville-Evrard, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT02383693

Collaborator

(none)

Enrollment

Location

Arms

107

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Device: Repetitive Transcranial Magnetic Stimulation	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: repetitive transcranial magnetic stimulation Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks	Device: Repetitive Transcranial Magnetic Stimulation Repetitive Transcranial Magnetic Stimulation Other Names: TMS
Sham Comparator: Sham comparator Placebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks	Device: Repetitive Transcranial Magnetic Stimulation Repetitive Transcranial Magnetic Stimulation Other Names: TMS

Arm

Intervention/Treatment

Active Comparator: repetitive transcranial magnetic stimulation

Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks

Device: Repetitive Transcranial Magnetic Stimulation

Repetitive Transcranial Magnetic Stimulation

Other Names:

TMS

Sham Comparator: Sham comparator

Placebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks

Device: Repetitive Transcranial Magnetic Stimulation

Repetitive Transcranial Magnetic Stimulation

Other Names:

TMS

Outcome Measures

Primary Outcome Measures

'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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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