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.”

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.

rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency :

1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.

Intervention(s) in this Clinical Trial

• 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: 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: 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week)
• Experimental: B
  • active rTMS (5 times/week) and sham venlafaxine (150 mg/day)
• Sham Comparator: C
  • sham rTMS (5 times/week) and active venlafaxine (150 mg/day)

Primary 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)
  • Time Frame: 2 to 6 weeks
    Safety Issue?: No

Secondary Measures

• Onset of action for remission and response (HDRS-17 diminution > 50%)
  • Time Frame: 2 to 6 weeks
    Safety Issue?: No
• Anxiety will be assessed using the Covi Anxiety Scale.
  • Time Frame: 2 to 6 weeks
    Safety Issue?: No
• Side effects will be assessed using the UKU Scale.
  • Time Frame: 2 to 6 weeks
    Safety Issue?: Yes
• 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
    Safety Issue?: No
• Onset of action using the Clinical Global Impressions scale (CGI)
  • Time Frame: 2 to 6 weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Club rTMS et Psychiatrie Other

Overall Clinical Trial Officials and Contacts

Emmanuel POULET, MD, PhD Principal Investigator Centre Hospitalier Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO  

Overall Contact: Emmanuel POULET, MD, PhD 0033 4 37 91 51 00 emmanuel.poulet@ch-le-vinatier.fr

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00714090

Study ID Number: SAD-001

ClinicalTrials.gov Identifier: NCT00714090

Health Authority: France: Afssaps - French Health Products Safety Agency

Website of the "Club rTMS et Psychiatrie"