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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT01409304 |
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Date of registration:
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02/08/2011 |
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Primary sponsor: |
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Public title:
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Effectiveness of Deep Transcranial Magnetic Stimulation in Depression
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Scientific title:
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Effectiveness of Deep Transcranial Magnetic Stimulation for Treating Major Depression: a Pilot Study |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01409304 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Marcelo T Berlim, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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McGill University & Douglas Mental Health University Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Presence of a current major depressive disorder (according to the DSM-IV-TR) that has
not improved after = 1 but = 5 adequate antidepressant trial(s) in the current
episode
- Baseline score = 15 on the QIDS-C
- Stable medication regimen (> 4 weeks)
Exclusion Criteria:
- Psychotic features in the current episode
- Lifetime history of psychotic disorders and/or bipolar I or II disorders
- Substance or alcohol abuse/dependence in the past 6 months
- Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
- Uncontrolled medical disease (e.g., cardiovascular, renal)
- Pregnancy and/or lactation
- Presence of a specific contraindication for DTMS (e.g., personal history of epilepsy,
metallic head implant)
- Hearing loss
- Personal history of abnormal brain MRI findings
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Intervention(s)
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Device: Deep Transcranial Magnetic Stimulation (DTMS)
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Primary Outcome(s)
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21-item Hamilton Depression Rating Scale (HAM-D21)
[Time Frame: week 5]
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Secondary Outcome(s)
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Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
[Time Frame: week 5]
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Secondary ID(s)
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DTMS-ERB10/18-2011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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