Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

Unipolar Depression Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714090
• Other study ID #: SAD-001
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2008
• Last updated: July 18, 2013
• Start date: May 2008
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Club rTMS et Psychiatrie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Unipolar Depression

Intervention

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
• 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.

Locations

Country	Name	City	State
France	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	St Etienne cedex
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (3)

Lead Sponsor	Collaborator
Club rTMS et Psychiatrie	Ministry of Health, France, Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		2 to 6 weeks	No
Secondary	Onset of action for remission and response (HDRS-17 diminution > 50%)		2 to 6 weeks	No
Secondary	Anxiety will be assessed using the Covi Anxiety Scale.		2 to 6 weeks	No
Secondary	Side effects will be assessed using the UKU Scale.		2 to 6 weeks	Yes
Secondary	Evaluation of depression using 2 other scales : the Montgomery Asberg Depression Rating Scale (MADRS) and the Beck Depression Inventory scale (BDI-13)		2 to 6 weeks	No
Secondary	Onset of action using the Clinical Global Impressions scale (CGI)		2 to 6 weeks	No