Repetitive Transcranial Magnetic Stimulation Compared or Associated With Venlafaxine for Depressive Disorder

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 3

Conditions: Depression

Treatments: Other: sham rTMS and active Venlafaxine; Other: active rTMS and active Venlafaxine; Other: active rTMS and sham Venlafaxine

Study type: Interventional

Funder types: Other

Identifiers

NCT01370304

20110526-09

Details and patient eligibility

About

The purpose of this study is to treat participants with a diagnosis of depressive disorder to assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of depressive disorders compared venlafaxine only (the optimal medication) and to rTMS only. fMRI will be performed to determine if treatment response is related to changes in fMRI, and use it to investigate the respondence to the treatments.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years and older
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

active rTMS and active Venlafaxine

Experimental group

Treatment:

Other: active rTMS and active Venlafaxine

active rTMS and sham Venlafaxine

Experimental group

Treatment:

Other: active rTMS and sham Venlafaxine

sham rTMS and active Venlafaxine

Sham Comparator group

Treatment:

Other: sham rTMS and active Venlafaxine