Depression
Conditions
Keywords
repetitive Transcranial Magnetic Stimulation (rTMS), Depression, Venlafaxine, fMRI
Brief 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.
Interventions
OTHERactive 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
OTHERactive 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
OTHERsham 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
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure is remission | 1-6 weeks | It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 \< 8) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fMRI | 0,6 weeks | — |
| CGI | 1-6 weeks | Using the Clinical Global Impression scale(CGI) |
| QIDS-C30 | 1-6 weeks | — |
| UKU Scale | 1-6 weeks | Side effects will be assessed using the UKU Scale |
Countries
China
Contacts
Primary ContactYunchun Chen, Ph.D
Backup ContactShufang Feng, Ph.D
Outcome results
None listed