Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression
NCT ID: NCT00714090
Last Updated: 2013-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
170 participants
INTERVENTIONAL
2008-05-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week)
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
B
active rTMS (5 times/week) and sham venlafaxine (150 mg/day)
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.
C
sham rTMS (5 times/week) and active venlafaxine (150 mg/day)
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.
Interventions
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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
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Club rTMS et Psychiatrie
OTHER
Responsible Party
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Dr Emmanuel POULET
Medical Doctor
Principal Investigators
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Emmanuel POULET, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
EA 4615 - SIPAD, Unité de Recherche UCB Lyon 1/CH Le Vinatier - Department of Psychiatry - Service du Pr d'AMATO
Locations
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C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte
Besançon, , France
C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO
Bron, , France
C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A
Clermont-Ferrand, , France
Hôpital Louis Mourier
Colombes, , France
C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie
Dijon, , France
C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie
Grenoble, , France
ASM Limoux
Lézignan-Corbières, , France
Hôpital Fontan - C.H.R.U. Lille
Lille, , France
C.H. Sainte Marguerite
Marseille, , France
CHU - Hôpital La Colombière
Montpellier, , France
Hôpital Pasteur - CHU Nice
Nice, , France
Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique
Paris, , France
C.H.U. de POITIERS
Poitiers, , France
C.H.U. - C.H. Guillaume Régnier
Rennes, , France
C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie
Rouen, , France
EPS de Ville Evrard - Unité de Saint-Denis
Saint-Denis, , France
CHU St Etienne - Hôpital Nord
Saint-Etienne, , France
Centre Hospitalier Princesse Grace
Monaco, , Monaco
Countries
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References
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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.
Other Identifiers
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SAD-001
Identifier Type: -
Identifier Source: org_study_id
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