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

Information source: Xijing Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: active rTMS and active Venlafaxine (Other); active rTMS and sham Venlafaxine (Other); sham rTMS and active Venlafaxine (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Xijing Hospital

Official(s) and/or principal investigator(s):
Qingrong Tan, Ph.D, Study Chair, Affiliation: Department of Psychiatry, Xi Jing hospital, Xi'an, China

Overall contact:
Yunchun Chen, Ph.D, Phone: +086-13720582601, Email: Yunchunchen@163.com

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.

Clinical Details

Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) Compared or Associated With Venlafaxine for Depressive Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The primary outcome measure is remission

Secondary outcome:

fMRI

CGI

QIDS-C30

UKU Scale

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Yunchun Chen, Ph.D, Phone: +086-13720582601, Email: Yunchunchen@163.com

Yun chun Chen, Xi'an, Shaanxi 710032, China; Recruiting
Yun chun Chen, Ph.D, Phone: +086-13720582601, Email: Yunchunchen@163.com
Shufang Feng, Ph.D, Phone: +086-13227807801, Email: fangshuan1984@yahoo.com.cn
Zhuo Wang, M.D, Principal Investigator
Additional Information

Starting date: June 2011
Last updated: February 13, 2012

Page last updated: August 23, 2015

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