Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.

Official Title
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Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.

Conditions
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Unipolar Depression

Intervention / Treatment
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* Other: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed
* Other: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine
* Other: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Clinical diagnosis of major depressive disorder (DSM-IV) HDRS-17 items > 20 Failure of one antidepressant treatment (efficacious doses for 6 weeks at least) Exclusion Criteria: I or II bipolar disorder Psychotic features Failure of one previous venlafaxine treatment Addiction comorbidity or schizophrenia comorbidity Involuntary hospitalization Seizures history Pregnancy or breastfeeding Somatic comorbidity able to impact on cognitive functions

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week) | Other: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed<br>* 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<br>* Other names: repetitive transcranial magnetic stimulator, Alpine Biomed;|
| Experimental: B<br>active rTMS (5 times/week) and sham venlafaxine (150 mg/day) | Other: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine<br>* 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.<br>* Other names: venlafaxine, Wyeth;|
| Sham Comparator: C<br>sham rTMS (5 times/week) and active venlafaxine (150 mg/day) | Other: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine<br>* 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.<br>* Other names: venlafaxine, Wyeth;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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repetitive Transcranial Magnetic Stimulation (rTMS), Major depressive disorders, Depression, Venlafaxine