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number of center : 1
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| repetitive transcranial magnetic stimulation | Active Comparator | Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks |
|
| Sham comparator | Sham Comparator | Placebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Device | Repetitive Transcranial Magnetic Stimulation |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique januel, MD.Phd | Contact | 0143093232 | domjanuel@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rene BENADHIRA, MD | E.P.S ville Evrard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de Recherche Clinique | Recruiting | Neuilly-sur-Marne | Île-de-France Region | 93330 | France |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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|
| D001519 |
| Behavior |