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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: |
NCT00191932 |
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Date of registration:
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12/09/2005 |
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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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Switching to Duloxetine From Other Antidepressants
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Scientific title:
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Switching to Duloxetine From Other Antidepressants: A Regional Multicentre Trial Comparing Two Switching Techniques |
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Date of first enrolment:
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August 2004 |
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Target sample size:
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360 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00191932 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Ireland
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Italy
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Spain
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United Kingdom
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and female outpatients of at least 18 years of age, who meet criteria for Major
Depressive Disorder (MDD)
- Currently non- or only partially-responsive to an SSRI antidepressant after at least
5 weeks of treatment
Exclusion Criteria include:
- Current primary Axis I disorder other than MDD
- Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
- Patients judged to be at serious suicidal risk.
- Serious medical illness
Age minimum:
18 Years
Age maximum:
N/A
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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Drug: Duloxetine
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Primary Outcome(s)
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To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch
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Secondary Outcome(s)
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To compare the efficacy, health outcomes, safety and tolerability associated with the above two switching methods, as measured by HAMD17, CGI-S, PGI-I, SF-36, spontaneously reported adverse events , vital signs and other measures.
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Secondary ID(s)
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F1J-MC-HMDG
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8604
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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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