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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01370304
• Other study ID #: 20110526-09
• Status: Recruiting
• Phase: Phase 3
• First received: June 8, 2011
• Last updated: February 13, 2012
• Start date: June 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2012
• Source: Xijing Hospital
• Contact: Yunchun Chen, Ph.D
• Phone: +086-13720582601
• Email: Yunchunchen[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
China	Yun chun Chen	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is remission	It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)	1-6 weeks	No
Secondary	fMRI		0,6 weeks	No
Secondary	CGI	Using the Clinical Global Impression scale(CGI)	1-6 weeks	No
Secondary	QIDS-C30		1-6 weeks	No
Secondary	UKU Scale	Side effects will be assessed using the UKU Scale	1-6 weeks	Yes