Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

Phase 3

Completed

• Conditions: Unipolar Depression
• Interventions: 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

• Registration Number: NCT00714090
• Lead Sponsor: Club rTMS et Psychiatrie

Brief Summary

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

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

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-07-10
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-14
• Primary Completion: 2012-07
• Status Verified: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-18
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed	Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week)
B	active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine	active rTMS (5 times/week) and sham venlafaxine (150 mg/day)
C	sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine	sham rTMS (5 times/week) and active venlafaxine (150 mg/day)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (18)

C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte; 🇫🇷 Besançon, France

ASM Limoux; 🇫🇷 Lézignan-Corbières, France

C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A; 🇫🇷 Clermont Ferrand, France

C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie; 🇫🇷 Dijon, France

Hôpital Louis Mourier; 🇫🇷 Colombes, France

CHU - Hôpital La Colombière; 🇫🇷 Montpellier, France

Hôpital Pasteur - CHU Nice; 🇫🇷 Nice, France

Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique; 🇫🇷 Paris, France

C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO; 🇫🇷 Bron, France

C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie; 🇫🇷 Grenoble, France

Hôpital Fontan - C.H.R.U. Lille; 🇫🇷 Lille, France

C.H. Sainte Marguerite; 🇫🇷 Marseille, France

CHU St Etienne - Hôpital Nord; 🇫🇷 St Etienne cedex, France

C.H.U. - C.H. Guillaume Régnier; 🇫🇷 Rennes, France

EPS de Ville Evrard - Unité de Saint-Denis; 🇫🇷 Saint-Denis, France

C.H.U. de POITIERS; 🇫🇷 Poitiers, France

C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie; 🇫🇷 Rouen, France

Centre Hospitalier Princesse Grace; 🇲🇨 Monaco, Monaco