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Clinical Trials/NCT01370304
NCT01370304
Unknown
Phase 3

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

Xijing Hospital1 site in 1 country60 target enrollmentJune 2011
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ConditionsDepression

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Depression
Sponsor
Xijing Hospital
Enrollment
60
Locations
1
Primary Endpoint
The primary outcome measure is remission
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
December 2013
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Principal Investigator
Principal Investigator

fengshufang

Fourth Military Medical University, Department of Psychosomatics, Xijing Hospital

Xijing Hospital

Eligibility 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

Outcomes

Primary Outcomes

The primary outcome measure is remission

Time Frame: 1-6 weeks

It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 \< 8)

Secondary Outcomes

  • QIDS-C30(1-6 weeks)
  • fMRI(0,6 weeks)
  • CGI(1-6 weeks)
  • UKU Scale(1-6 weeks)

Study Sites (1)

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