Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

Club rTMS et Psychiatrie

Status and phase: Completed; Phase 3

Conditions: Unipolar Depression

Treatments: Other: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine; Other: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed; Other: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00714090

SAD-001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 3 patient groups

A

Active Comparator group

Description:

Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week)

Treatment:

Other: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed

B

Experimental group

Description:

active rTMS (5 times/week) and sham venlafaxine (150 mg/day)

Treatment:

Other: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine

C

Sham Comparator group

Description:

sham rTMS (5 times/week) and active venlafaxine (150 mg/day)

Treatment:

Other: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine