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

Centre hospitalier de Ville-Evrard, France

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Major Depressive Disorder

Treatments: Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02383693

2007-A00244-49

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

repetitive transcranial magnetic stimulation

Active Comparator group

Description:

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Sham comparator

Sham Comparator group

Description:

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation