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Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

Information source: Club rTMS et Psychiatrie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Unipolar Depression

Intervention: 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 (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Club rTMS et Psychiatrie

Official(s) and/or principal investigator(s):
Emmanuel POULET, MD, PhD, Principal Investigator, Affiliation: EA 4615 - SIPAD, Unité de Recherche UCB Lyon 1/CH Le Vinatier - Department of Psychiatry - Service du Pr d'AMATO

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome:

Onset of action for remission and response (HDRS-17 diminution > 50%)

Anxiety will be assessed using the Covi Anxiety Scale.

Side effects will be assessed using the UKU Scale.

Evaluation of depression using 2 other scales : the Montgomery Asberg Depression Rating Scale (MADRS) and the Beck Depression Inventory scale (BDI-13)

Onset of action using the Clinical Global Impressions scale (CGI)

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and 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, 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

Hôpital Fontan - C.H.R.U. Lille, Lille 59000, France

ASM Limoux, Lézignan-Corbières 11200, 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, St Etienne cedex 42055, France

Centre Hospitalier Princesse Grace, Monaco 98000, Monaco

Additional Information

Website of the "Club rTMS et Psychiatrie"

Starting date: May 2008
Last updated: July 18, 2013

Page last updated: August 23, 2015

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