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Switching to Duloxetine From Other Antidepressants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00191932
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 25, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date July 25, 2006
Study Start Date  ICMJE August 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)		 To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)		 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Switching to Duloxetine From Other Antidepressants
Official Title  ICMJE Switching to Duloxetine From Other Antidepressants: A Regional Multicentre Trial Comparing Two Switching Techniques
Brief Summary A multicentre, randomised, open label study of out-patients with major depression who have failed to respond adequately to antidepressant treatment for their current episode of depression. The study compares outcomes associated with two methods of switching from current antidepressant to duloxetine
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: Duloxetine
Study Arms  ICMJE Not Provided
Publications * Perahia DG, Quail D, Desaiah D, Corruble E, Fava M. Switching to duloxetine from selective serotonin reuptake inhibitor antidepressants: a multicenter trial comparing 2 switching techniques. J Clin Psychiatry. 2008 Jan;69(1):95-105. doi: 10.4088/jcp.v69n0113.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 12, 2005)		 360
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Ireland,   Spain,   United Kingdom
Removed Location Countries Italy
 
Administrative Information
NCT Number  ICMJE NCT00191932
Other Study ID Numbers  ICMJE 8604
F1J-MC-HMDG
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP