Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

July 18, 2013 updated by: Dr Emmanuel POULET, Club rTMS et Psychiatrie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte
      • Bron, France, 69500
        • C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO
      • Clermont Ferrand, France, 63000
        • C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A
      • Colombes, France, 92700
        • Hopital Louis Mourier
      • Dijon, France, 21000
        • C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie
      • Grenoble, France, 38000
        • C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie
      • Lille, France, 59000
        • Hôpital Fontan - C.H.R.U. Lille
      • Lézignan-Corbières, France, 11200
        • ASM Limoux
      • Marseille, France, 13000
        • C.H. Sainte Marguerite
      • Montpellier, France, 34000
        • CHU - Hôpital La Colombière
      • Nice, France, 06000
        • Hôpital Pasteur - CHU Nice
      • Paris, France, 75014
        • Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique
      • Poitiers, France, 86000
        • C.H.U. de Poitiers
      • Rennes, France, 35000
        • C.H.U. - C.H. Guillaume Régnier
      • Rouen, France, 76000
        • C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie
      • Saint-Denis, France, 93200
        • EPS de Ville Evrard - Unité de Saint-Denis
      • St Etienne cedex, France, 42055
        • CHU ST Etienne - Hôpital Nord
  • Monaco
      • Monaco, Monaco, 98000
        • Centre Hospitalier Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
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

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

Other Names:
  • venlafaxine, Wyeth
  • repetitive transcranial magnetic stimulator, Inomed
  • repetitive transcranial magnetic stimulator, Alpine Biomed
EXPERIMENTAL: B
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
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.
Other Names:
  • venlafaxine, Wyeth
  • repetitive transcranial magnetic stimulator, Inomed
  • repetitive transcranial magnetic stimulator, Alpine Biomed
SHAM_COMPARATOR: C
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
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.
Other Names:
  • venlafaxine, Wyeth
  • repetitive transcranial magnetic stimulator, Inomed
  • repetitive transcranial magnetic stimulator, Alpine Biomed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: 2 to 6 weeks
2 to 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Onset of action for remission and response (HDRS-17 diminution > 50%)
Time Frame: 2 to 6 weeks
2 to 6 weeks
Anxiety will be assessed using the Covi Anxiety Scale.
Time Frame: 2 to 6 weeks
2 to 6 weeks
Side effects will be assessed using the UKU Scale.
Time Frame: 2 to 6 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)
Time Frame: 2 to 6 weeks
2 to 6 weeks
Onset of action using the Clinical Global Impressions scale (CGI)
Time Frame: 2 to 6 weeks
2 to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Club rTMS et Psychiatrie

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer
Ministry of Health, France

Investigators

  • Principal Investigator: Emmanuel POULET, MD, PhD, EA 4615 - SIPAD, Unité de Recherche UCB Lyon 1/CH Le Vinatier - Department of Psychiatry - Service du Pr d'AMATO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

July 10, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (ESTIMATE)

July 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2013

Last Update Submitted That Met QC Criteria

July 18, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAD-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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