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

NCT ID: NCT01370304

Last Updated: 2012-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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active rTMS and active Venlafaxine

Group Type EXPERIMENTAL

active rTMS and active Venlafaxine

Intervention Type OTHER

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

active rTMS and sham Venlafaxine

Group Type EXPERIMENTAL

active rTMS and sham Venlafaxine

Intervention Type OTHER

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

sham rTMS and active Venlafaxine

Group Type SHAM_COMPARATOR

sham rTMS and active Venlafaxine

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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venlafaxine: Wyeth rTMS: MagVenture venlafaxine: Wyeth rTMS: MagVenture venlafaxine: Wyeth rTMS: MagVenture

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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fengshufang

Fourth Military Medical University, Department of Psychosomatics, Xijing Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qingrong Tan, Ph.D

Role: STUDY_CHAIR

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

Locations

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Yun chun Chen

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunchun Chen, Ph.D

Role: CONTACT

+086-13720582601

Shufang Feng, Ph.D

Role: CONTACT

+086-13227807801

Facility Contacts

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Yun chun Chen, Ph.D

Role: primary

+086-13720582601

Shufang Feng, Ph.D

Role: backup

+086-13227807801

Other Identifiers

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20110526-09

Identifier Type: -

Identifier Source: org_study_id

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