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Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

Sponsor
Club rTMS et Psychiatrie (Other)
Overall Status
Completed
CT.gov ID
NCT00714090
Collaborator
Ministry of Health, France (Other), Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
170
Enrollment
18
Locations
3
Arms
62
Duration (Months)
9.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

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:
  • repetitive transcranial magnetic stimulator, Inomed
  • repetitive transcranial magnetic stimulator, Alpine Biomed
  • venlafaxine, Wyeth

    		•
    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:
  • repetitive transcranial magnetic stimulator, Inomed
  • repetitive transcranial magnetic stimulator, Alpine Biomed
  • venlafaxine, Wyeth

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Onset of action for remission and response (HDRS-17 diminution > 50%) [2 to 6 weeks]

    2. Anxiety will be assessed using the Covi Anxiety Scale. [2 to 6 weeks]

    3. Side effects will be assessed using the UKU Scale. [2 to 6 weeks]

    4. 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]

    5. Onset of action using the Clinical Global Impressions scale (CGI) [2 to 6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Club rTMS et Psychiatrie
    • Ministry of Health, France
    • Wyeth is now a wholly owned subsidiary of Pfizer

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Emmanuel POULET, Medical Doctor, Club rTMS et Psychiatrie
    ClinicalTrials.gov Identifier:
    NCT00714090
    Other Study ID Numbers:
    • SAD-001
    First Posted:
    Jul 14, 2008
    Last Update Posted:
    Jul 19, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Dr Emmanuel POULET, Medical Doctor, Club rTMS et Psychiatrie
    repetitive Transcranial Magnetic Stimulation (rTMS)
    Major depressive disorders
    Depression
    Venlafaxine
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Venlafaxine Hydrochloride

    Study Results

    No Results Posted as of Jul 19, 2013