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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active rTMS and active Venlafaxine | Experimental |
| |
| active rTMS and sham Venlafaxine | Experimental |
| |
| sham rTMS and active Venlafaxine | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active rTMS and active Venlafaxine | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is remission | It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8) | 1-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI | 0,6 weeks | |
| CGI | Using the Clinical Global Impression scale(CGI) | 1-6 weeks |
| QIDS-C30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunchun Chen, Ph.D | Contact | +086-13720582601 | Yunchunchen@163.com | |
| Shufang Feng, Ph.D | Contact | +086-13227807801 | fangshuan1984@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qingrong Tan, Ph.D | Department of Psychiatry, Xi Jing hospital, Xi'an, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yun chun Chen | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
|
| active rTMS and sham Venlafaxine | 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 | 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 |
|
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| 1-6 weeks |
| UKU Scale | Side effects will be assessed using the UKU Scale | 1-6 weeks |