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

A

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

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

Trial contacts and locations

0

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Central trial contact

Shufang Feng, Ph.D; Yunchun Chen, Ph.D

Data sourced from clinicaltrials.gov

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