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Trial record 1 of 1 for:    NCT00714090
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Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

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ClinicalTrials.gov Identifier: NCT00714090
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : July 19, 2013
Sponsor:
Collaborators:
Ministry of Health, France
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Dr Emmanuel POULET, Club rTMS et Psychiatrie

Tracking Information
First Submitted Date  ICMJE July 10, 2008
First Posted Date  ICMJE July 14, 2008
Last Update Posted Date July 19, 2013
Study Start Date  ICMJE May 2008
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2008)
  • Onset of action for remission and response (HDRS-17 diminution > 50%) [ Time Frame: 2 to 6 weeks ]
  • Anxiety will be assessed using the Covi Anxiety Scale. [ Time Frame: 2 to 6 weeks ]
  • Side effects will be assessed using the UKU Scale. [ Time Frame: 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 ]
  • Onset of action using the Clinical Global Impressions scale (CGI) [ Time Frame: 2 to 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression
Official Title  ICMJE Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Unipolar Depression
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week)
    Intervention: Other: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed
  • Experimental: B
    active rTMS (5 times/week) and sham venlafaxine (150 mg/day)
    Intervention: Other: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine
  • Sham Comparator: C
    sham rTMS (5 times/week) and active venlafaxine (150 mg/day)
    Intervention: Other: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2013)
170
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2008)
363
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Monaco
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00714090
Other Study ID Numbers  ICMJE SAD-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Emmanuel POULET, Club rTMS et Psychiatrie
Study Sponsor  ICMJE Club rTMS et Psychiatrie
Collaborators  ICMJE
  • Ministry of Health, France
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
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
PRS Account Club rTMS et Psychiatrie
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP