Repetitive Transcranial Magnetic Stimulation Compared or Associated With Venlafaxine for Depressive Disorder
Information source: Xijing Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
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: fMRICGI 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
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