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

Primary Purpose

Depression

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
active rTMS and active Venlafaxine
active rTMS and sham Venlafaxine
sham rTMS and active Venlafaxine
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring repetitive Transcranial Magnetic Stimulation (rTMS), Depression, Venlafaxine, fMRI

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Yun chun ChenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

active rTMS and active Venlafaxine

active rTMS and sham Venlafaxine

sham rTMS and active Venlafaxine

Arm Description

Outcomes

Primary Outcome Measures

The primary outcome measure is remission
It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)

Secondary Outcome Measures

fMRI
CGI
Using the Clinical Global Impression scale(CGI)
QIDS-C30
UKU Scale
Side effects will be assessed using the UKU Scale

Full Information

First Posted
June 8, 2011
Last Updated
February 13, 2012
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01370304
Brief Title
Repetitive Transcranial Magnetic Stimulation Compared or Associated With Venlafaxine for Depressive Disorder
Official Title
Repetitive Transcranial Magnetic Stimulation (rTMS) Compared or Associated With Venlafaxine for Depressive Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
repetitive Transcranial Magnetic Stimulation (rTMS), Depression, Venlafaxine, fMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active rTMS and active Venlafaxine
Arm Type
Experimental
Arm Title
active rTMS and sham Venlafaxine
Arm Type
Experimental
Arm Title
sham rTMS and active Venlafaxine
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
active rTMS and active Venlafaxine
Other Intervention Name(s)
venlafaxine: Wyeth, rTMS: MagVenture
Intervention Description
rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks Venlafaxine: LP:75mg:1capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks
Intervention Type
Other
Intervention Name(s)
active rTMS and sham Venlafaxine
Other Intervention Name(s)
venlafaxine: Wyeth, rTMS: MagVenture
Intervention Description
rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s. 5 sessions per week for 4-6 weeks
Intervention Type
Other
Intervention Name(s)
sham rTMS and active Venlafaxine
Other Intervention Name(s)
venlafaxine: Wyeth, rTMS: MagVenture
Intervention Description
rTMS parameters :same coil, same number of pulses but using an angled coil(90 degree)over the frontotemporal region Venlafaxine: LP:75mg:1capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks
Primary Outcome Measure Information:
Title
The primary outcome measure is remission
Description
It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)
Time Frame
1-6 weeks
Secondary Outcome Measure Information:
Title
fMRI
Time Frame
0,6 weeks
Title
CGI
Description
Using the Clinical Global Impression scale(CGI)
Time Frame
1-6 weeks
Title
QIDS-C30
Time Frame
1-6 weeks
Title
UKU Scale
Description
Side effects will be assessed using the UKU Scale
Time Frame
1-6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunchun Chen, Ph.D
Phone
+086-13720582601
Email
Yunchunchen@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shufang Feng, Ph.D
Phone
+086-13227807801
Email
fangshuan1984@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingrong Tan, Ph.D
Organizational Affiliation
Department of Psychiatry, Xi Jing hospital, Xi'an, China
Official's Role
Study Chair
Facility Information:
Facility Name
Yun chun Chen
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun chun Chen, Ph.D
Phone
+086-13720582601
Email
Yunchunchen@163.com
First Name & Middle Initial & Last Name & Degree
Shufang Feng, Ph.D
Phone
+086-13227807801
Email
fangshuan1984@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Zhuo Wang, M.D

12. IPD Sharing Statement

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

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