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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: repetitive transcranial magnetic stimulation<br>Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks | Device: Repetitive Transcranial Magnetic Stimulation<br>* Repetitive Transcranial Magnetic Stimulation<br>* Other names: TMS;|
| Sham Comparator: Sham comparator<br>Placebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks | Device: Repetitive Transcranial Magnetic Stimulation<br>* Repetitive Transcranial Magnetic Stimulation<br>* Other names: TMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 'Hamilton depression rating scale (HDRS) | 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. | one years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, Repetitive Transcranial Magnetic Stimulation, tolerability, efficiency, TMS, refractory