Major Depression Clinical Trial
Official title:
Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression
Verified date | February 2011 |
Source | Institute of Neuroscience, Florence, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the treatment of resistant depression. No accordance exists on which are the involved mechanisms of action and on which stimulation parameters, frequency and side are optimal.
Status | Completed |
Enrollment | 16 |
Est. completion date | January 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Diagnostic and Statistical Manual-IV criteria for Depressive Major Episode Hamilton Rating Scale for Depression -28 (Ham-D)score = 18 - Failure to respond to a minimum of two courses of antidepressant medications for at least 6 weeks Exclusion Criteria: - Any comorbid axis I disorder (except simple and social phobia) - Any other significant medical, particularly neurologic, illnesses (seizures, head trauma and brain lesions) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Institute of Neuroscience | Florence |
Lead Sponsor | Collaborator |
---|---|
Institute of Neuroscience, Florence, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression Scale (HAM-D) | at baseline and 3rd week | No | |
Secondary | Clinical Global Impression Scale (CGI) | baseline and 3rd week | No |
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