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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT02125799 |
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Date of registration:
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25/04/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Accelerated rTMS for Treatment-Resistant Major Depression
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Scientific title:
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A Pilot Trial on the Effectiveness and Tolerability of Accelerated High Frequency Repetitive Transcranial Magnetic Stimulation for Treating Resistant Major Depression |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02125799 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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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 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 - Dept of Psychiatry |
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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 = 2 adequate antidepressant trial(s) in the current episode;
- Baseline score = 13 on the QIDS-C
- Stable medication regimen (>= 4 weeks) prior to study enrolment
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 rTMS (e.g., personal history of epilepsy,
metallic head implant)
- Hearing loss
Age minimum:
18 Years
Age maximum:
75 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: Accelerated HF-rTMS (Magstim Rapid 2 stimulator)
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Primary Outcome(s)
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Quick Inventory of Depressive Symptomatology - Clinician Version
[Time Frame: Week 3]
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Secondary ID(s)
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IRB12/38
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ERB12/38
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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