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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only.
rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week) |
|
| B | Experimental | active rTMS (5 times/week) and sham venlafaxine (150 mg/day) |
|
| C | Sham Comparator | sham rTMS (5 times/week) and active venlafaxine (150 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed | Other | active venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks. active rTMS : 5 sessions per week for 2 to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is remission. It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)and Montgomery Asberg Depression Rating Scale (MADRS) | 2 to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of action for remission and response (HDRS-17 diminution > 50%) | 2 to 6 weeks | |
| Anxiety will be assessed using the Covi Anxiety Scale. | 2 to 6 weeks | |
| Side effects will be assessed using the UKU Scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel POULET, MD, PhD | EA 4615 - SIPAD, Unité de Recherche UCB Lyon 1/CH Le Vinatier - Department of Psychiatry - Service du Pr d'AMATO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte | Besançon | 25000 | France | |||
| C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25192980 | Derived | Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group; Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7. |
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|
|
| active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine | Other | active rTMS : 5 sessions per week for 2 to 6 weeks sham venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks. |
|
|
| sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine | Other | sham rTMS : 5 sessions per week for 2 to 6 weeks active venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks. |
|
|
| 2 to 6 weeks |
| Evaluation of depression using 2 other scales : the Montgomery Asberg Depression Rating Scale (MADRS) and the Beck Depression Inventory scale (BDI-13) | 2 to 6 weeks |
| Onset of action using the Clinical Global Impressions scale (CGI) | 2 to 6 weeks |
| Bron |
| 69500 |
| France |
| C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A | Clermont-Ferrand | 63000 | France |
| Hôpital Louis Mourier | Colombes | 92700 | France |
| C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie | Dijon | 21000 | France |
| C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie | Grenoble | 38000 | France |
| ASM Limoux | Lézignan-Corbières | 11200 | France |
| Hôpital Fontan - C.H.R.U. Lille | Lille | 59000 | France |
| C.H. Sainte Marguerite | Marseille | 13000 | France |
| CHU - Hôpital La Colombière | Montpellier | 34000 | France |
| Hôpital Pasteur - CHU Nice | Nice | 06000 | France |
| Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique | Paris | 75014 | France |
| C.H.U. de POITIERS | Poitiers | 86000 | France |
| C.H.U. - C.H. Guillaume Régnier | Rennes | 35000 | France |
| C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie | Rouen | 76000 | France |
| EPS de Ville Evrard - Unité de Saint-Denis | Saint-Denis | 93200 | France |
| CHU St Etienne - Hôpital Nord | Saint-Etienne | 42055 | France |
| Centre Hospitalier Princesse Grace | Monaco | 98000 | Monaco |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
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