Repetitive Transcranial Magnetic Stimulation Compared or Associated With Venlafaxine for Depressive Disorder

Study Overview
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Brief Summary
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The purpose of this study is to treat participants with a diagnosis of depressive disorder to assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of depressive disorders compared venlafaxine only (the optimal medication) and to rTMS only. fMRI will be performed to determine if treatment response is related to changes in fMRI, and use it to investigate the respondence to the treatments.

Official Title
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Repetitive Transcranial Magnetic Stimulation (rTMS) Compared or Associated With Venlafaxine for Depressive Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study

Conditions
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Depression

Intervention / Treatment
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* Other: active rTMS and active Venlafaxine
* Other: active rTMS and sham Venlafaxine
* Other: sham rTMS and active Venlafaxine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older 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: 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
Maximum Age: 60 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 |
| --- | --- |
| Experimental: active rTMS and active Venlafaxine<br> | Other: active rTMS and active Venlafaxine<br>* rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks Venlafaxine: LP:75mg:1capsule 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: rTMS: MagVenture;|
| Experimental: active rTMS and sham Venlafaxine<br> | Other: active rTMS and sham Venlafaxine<br>* rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s. 5 sessions per week for 4-6 weeks<br>* Other names: rTMS: MagVenture;|
| Sham Comparator: sham rTMS and active Venlafaxine<br> | Other: sham rTMS and active Venlafaxine<br>* rTMS parameters :same coil, same number of pulses but using an angled coil(90 degree)over the frontotemporal region Venlafaxine: LP:75mg:1capsule 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: rTMS: MagVenture;|

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) | 1-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI |  | 0,6 weeks | 
| CGI | Using the Clinical Global Impression scale(CGI) | 1-6 weeks | 
| QIDS-C30 |  | 1-6 weeks | 
| UKU Scale | Side effects will be assessed using the UKU Scale | 1-6 weeks | 

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