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Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

Primary Purpose

Unipolar Depression

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed
active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine
sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine
Sponsored by
Club rTMS et Psychiatrie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unipolar Depression focused on measuring repetitive Transcranial Magnetic Stimulation (rTMS), Major depressive disorders, Depression, Venlafaxine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte
  • C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO
  • C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A
  • Hôpital Louis Mourier
  • C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie
  • C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie
  • Hôpital Fontan - C.H.R.U. Lille
  • ASM Limoux
  • C.H. Sainte Marguerite
  • CHU - Hôpital La Colombière
  • Hôpital Pasteur - CHU Nice
  • Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique
  • C.H.U. de POITIERS
  • C.H.U. - C.H. Guillaume Régnier
  • C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie
  • EPS de Ville Evrard - Unité de Saint-Denis
  • CHU St Etienne - Hôpital Nord
  • Centre Hospitalier Princesse Grace

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Sham Comparator

Arm Label

A

B

C

Arm Description

Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week)

active rTMS (5 times/week) and sham venlafaxine (150 mg/day)

sham rTMS (5 times/week) and active venlafaxine (150 mg/day)

Outcomes

Primary Outcome Measures

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 Measures

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)

Full Information

First Posted
July 10, 2008
Last Updated
July 18, 2013
Sponsor
Club rTMS et Psychiatrie
Collaborators
Ministry of Health, France, Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00714090
Brief Title
Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression
Official Title
Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Club rTMS et Psychiatrie
Collaborators
Ministry of Health, France, Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression
Keywords
repetitive Transcranial Magnetic Stimulation (rTMS), Major depressive disorders, Depression, Venlafaxine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week)
Arm Title
B
Arm Type
Experimental
Arm Description
active rTMS (5 times/week) and sham venlafaxine (150 mg/day)
Arm Title
C
Arm Type
Sham Comparator
Arm Description
sham rTMS (5 times/week) and active venlafaxine (150 mg/day)
Intervention Type
Other
Intervention Name(s)
active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed
Other Intervention Name(s)
venlafaxine, Wyeth, repetitive transcranial magnetic stimulator, Inomed, repetitive transcranial magnetic stimulator, Alpine Biomed
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine
Other Intervention Name(s)
repetitive transcranial magnetic stimulator, Inomed, repetitive transcranial magnetic stimulator, Alpine Biomed, venlafaxine, Wyeth
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine
Other Intervention Name(s)
repetitive transcranial magnetic stimulator, Inomed, repetitive transcranial magnetic stimulator, Alpine Biomed, venlafaxine, Wyeth
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Onset of action for remission and response (HDRS-17 diminution > 50%)
Time Frame
2 to 6 weeks
Title
Anxiety will be assessed using the Covi Anxiety Scale.
Time Frame
2 to 6 weeks
Title
Side effects will be assessed using the UKU Scale.
Time Frame
2 to 6 weeks
Title
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
Title
Onset of action using the Clinical Global Impressions scale (CGI)
Time Frame
2 to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel POULET, MD, PhD
Organizational Affiliation
EA 4615 - SIPAD, Unité de Recherche UCB Lyon 1/CH Le Vinatier - Department of Psychiatry - Service du Pr d'AMATO
Official's Role
Principal Investigator
Facility Information:
Facility Name
C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Hôpital Fontan - C.H.R.U. Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
ASM Limoux
City
Lézignan-Corbières
ZIP/Postal Code
11200
Country
France
Facility Name
C.H. Sainte Marguerite
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
CHU - Hôpital La Colombière
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Hôpital Pasteur - CHU Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
C.H.U. de POITIERS
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
C.H.U. - C.H. Guillaume Régnier
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
EPS de Ville Evrard - Unité de Saint-Denis
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
Facility Name
CHU St Etienne - Hôpital Nord
City
St Etienne cedex
ZIP/Postal Code
42055
Country
France
Facility Name
Centre Hospitalier Princesse Grace
City
Monaco
ZIP/Postal Code
98000
Country
Monaco

12. IPD Sharing Statement

Citations:
PubMed Identifier
25192980
Citation
Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group; Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7.
Results Reference
derived

Learn more about this trial

Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

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