NCT01370304

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
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	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	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

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-12-01
• Completion: 2013-12-01
• First posted: 2011-06-09
• Last updated: 2012-02-15

Locations

1 site across 1 country: China