NCT01370304

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3 depression

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

1.5 years

First QC Date

June 8, 2011

Last Update Submit

February 13, 2012

Conditions

Depression

Keywords

repetitive Transcranial Magnetic Stimulation (rTMS)DepressionVenlafaxinefMRI

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is remission

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

    1-6 weeks

Secondary Outcomes (4)

  • fMRI

    0,6 weeks

  • CGI

    1-6 weeks

  • QIDS-C30

    1-6 weeks

  • UKU Scale

    1-6 weeks

Study Arms (3)

active rTMS and active Venlafaxine

EXPERIMENTAL
Other: active rTMS and active Venlafaxine

active rTMS and sham Venlafaxine

EXPERIMENTAL
Other: active rTMS and sham Venlafaxine

sham rTMS and active Venlafaxine

SHAM COMPARATOR
Other: sham rTMS and active Venlafaxine

Interventions

active rTMS and active VenlafaxineOTHER

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

Also known as: venlafaxine: Wyeth, rTMS: MagVenture
active rTMS and active Venlafaxine
active rTMS and sham VenlafaxineOTHER

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

Also known as: venlafaxine: Wyeth, rTMS: MagVenture
active rTMS and sham Venlafaxine
sham rTMS and active VenlafaxineOTHER

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

Also known as: venlafaxine: Wyeth, rTMS: MagVenture
sham rTMS and active Venlafaxine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yun chun Chen

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Qingrong Tan, Ph.D

    Department of Psychiatry, Xi Jing hospital, Xi'an, China

    STUDY CHAIR

Central Study Contacts

Yunchun Chen, Ph.D

CONTACT

+086-13720582601Yunchunchen@163.com

Shufang Feng, Ph.D

CONTACT

+086-13227807801fangshuan1984@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fourth Military Medical University, Department of Psychosomatics, Xijing Hospital

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 9, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations

CN(1)