Clinical trial NCT00714090: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unipolar Depression
Keywords: repetitive Transcranial Magnetic Stimulation (rTMS)
Major depressive disorders
Depression
Venlafaxine
Lead sponsor: Club rTMS et Psychiatrie
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2008-07-14
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 2 to 6 weeks
Secondary outcomes:
measure: Onset of action for remission and response (HDRS-17 diminution > 50%)
timeFrame: 2 to 6 weeks
measure: Anxiety will be assessed using the Covi Anxiety Scale.
timeFrame: 2 to 6 weeks
measure: Side effects will be assessed using the UKU Scale.
timeFrame: 2 to 6 weeks
measure: Evaluation of depression using 2 other scales : the Montgomery Asberg Depression Rating Scale (MADRS) and the Beck Depression Inventory scale (BDI-13)
timeFrame: 2 to 6 weeks
measure: Onset of action using the Clinical Global Impressions scale (CGI)
timeFrame: 2 to 6 weeks
Other outcomes:
Locations:
city: Besançon
country: France
facility: C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte
city: Bron
country: France
facility: C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO
city: Clermont Ferrand
country: France
facility: C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Dijon
country: France
facility: C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie
city: Grenoble
country: France
facility: C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie
city: Lille
country: France
facility: Hôpital Fontan - C.H.R.U. Lille
city: Lézignan-Corbières
country: France
facility: ASM Limoux
city: Marseille
country: France
facility: C.H. Sainte Marguerite
city: Montpellier
country: France
facility: CHU - Hôpital La Colombière
city: Nice
country: France
facility: Hôpital Pasteur - CHU Nice
city: Paris
country: France
facility: Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique
city: Poitiers
country: France
facility: C.H.U. de POITIERS
city: Rennes
country: France
facility: C.H.U. - C.H. Guillaume Régnier
city: Rouen
country: France
facility: C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie
city: Saint-Denis
country: France
facility: EPS de Ville Evrard - Unité de Saint-Denis
city: St Etienne cedex
country: France
facility: CHU St Etienne - Hôpital Nord
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
affiliation: EA 4615 - SIPAD, Unité de Recherche UCB Lyon 1/CH Le Vinatier - Department of Psychiatry - Service du Pr d'AMATO
name: Emmanuel POULET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.