Status:
COMPLETED
Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression
Lead Sponsor:
Club rTMS et Psychiatrie
Collaborating Sponsors:
Ministry of Health, France
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Unipolar Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 t...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00714090
Start Date
May 1 2008
End Date
July 1 2013
Last Update
July 19 2013
Active Locations (18)
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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