Trial record 20 of 259 for:
rtms
Repetitive Transcranial Magnetic Stimulation Compared or Associated With Venlafaxine for Depressive Disorder
This study is currently recruiting participants.
Verified February 2012 by Xijing Hospital
Sponsor:
Xijing Hospital
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
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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:
|
| 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:
|
| 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:
|
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 May 19, 2013