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

Phase 3

• Conditions: Depression
• Interventions: Other: active rTMS and active Venlafaxine; Other: active rTMS and sham Venlafaxine; Other: sham rTMS and active Venlafaxine

• Registration Number: NCT01370304
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-15
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active rTMS and active Venlafaxine	active rTMS and active Venlafaxine	-
active rTMS and sham Venlafaxine	active rTMS and sham Venlafaxine	-
sham rTMS and active Venlafaxine	sham rTMS and active Venlafaxine	-

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is remission	1-6 weeks	It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 \< 8)

Secondary Outcome Measures

Name	Time	Method
QIDS-C30	1-6 weeks
fMRI	0,6 weeks
CGI	1-6 weeks	Using the Clinical Global Impression scale(CGI)
UKU Scale	1-6 weeks	Side effects will be assessed using the UKU Scale

Trial Locations

Locations (1)

Yun chun Chen; 🇨🇳 Xi'an, Shaanxi, China