Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

Phase 3

Completed

• Conditions: Unipolar Depression

• Registration Number: NCT00714090
• Lead Sponsor: Club rTMS et Psychiatrie

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-07-10
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-14
• Primary Completion: 2012-07
• Status Verified: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-18
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Onset of action for remission and response (HDRS-17 diminution > 50%)	2 to 6 weeks
Anxiety will be assessed using the Covi Anxiety Scale.	2 to 6 weeks
Side effects will be assessed using the UKU Scale.	2 to 6 weeks
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
Onset of action using the Clinical Global Impressions scale (CGI)	2 to 6 weeks

Trial Locations

Locations (18)

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

Hôpital Fontan - C.H.R.U. Lille; 🇫🇷 Lille, France

ASM Limoux; 🇫🇷 Lézignan-Corbières, France

C.H. Sainte Marguerite; 🇫🇷 Marseille, France

CHU - Hôpital La Colombière; 🇫🇷 Montpellier, France

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