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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
fengshufang, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01370304
First received: June 8, 2011
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Depression
Other: active rTMS and active Venlafaxine
Other: active rTMS and sham Venlafaxine
Other: sham rTMS and active Venlafaxine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation (rTMS) Compared or Associated With Venlafaxine for Depressive Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • The primary outcome measure is remission [ Time Frame: 1-6 weeks ] [ Designated as safety issue: No ]
    It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)


Secondary Outcome Measures:
  • fMRI [ Time Frame: 0,6 weeks ] [ Designated as safety issue: No ]
  • CGI [ Time Frame: 1-6 weeks ] [ Designated as safety issue: No ]
    Using the Clinical Global Impression scale(CGI)

  • QIDS-C30 [ Time Frame: 1-6 weeks ] [ Designated as safety issue: No ]
  • UKU Scale [ Time Frame: 1-6 weeks ] [ Designated as safety issue: Yes ]
    Side effects will be assessed using the UKU Scale


Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active rTMS and active Venlafaxine Other: active rTMS and active Venlafaxine

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

Other Names:
  • venlafaxine: Wyeth
  • rTMS: MagVenture
Experimental: active rTMS and sham Venlafaxine Other: active rTMS and sham Venlafaxine
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
Other Names:
  • venlafaxine: Wyeth
  • rTMS: MagVenture
Sham Comparator: sham rTMS and active Venlafaxine Other: sham rTMS and active Venlafaxine

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

Other Names:
  • venlafaxine: Wyeth
  • rTMS: MagVenture

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370304

Contacts
Contact: Yunchun Chen, Ph.D +086-13720582601 Yunchunchen@163.com
Contact: Shufang Feng, Ph.D +086-13227807801 fangshuan1984@yahoo.com.cn

Locations
China, Shaanxi
Yun chun Chen Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yun chun Chen, Ph.D    +086-13720582601    Yunchunchen@163.com   
Contact: Shufang Feng, Ph.D    +086-13227807801    fangshuan1984@yahoo.com.cn   
Principal Investigator: Zhuo Wang, M.D         
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Chair: Qingrong Tan, Ph.D Department of Psychiatry, Xi Jing hospital, Xi'an, China
  More Information

No publications provided

Responsible Party: fengshufang, Fourth Military Medical University, Department of Psychosomatics, Xijing Hospital, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01370304     History of Changes
Other Study ID Numbers: 20110526-09
Study First Received: June 8, 2011
Last Updated: February 13, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
repetitive Transcranial Magnetic Stimulation (rTMS)
Depression
Venlafaxine
fMRI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014