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Clinical Trials/NCT00191932
NCT00191932CompletedPhase 4

Switching to Duloxetine From Other Antidepressants: A Regional Multicentre Trial Comparing Two Switching Techniques

Eli Lilly and Company14 sites in 4 countries360 target enrollmentStarted: August 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
360
Locations
14
Primary Endpoint
To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • •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

Outcomes

Primary Outcomes

To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch

Secondary Outcomes

  • 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.

Investigators

Sponsor Class
Industry

Study Sites (14)

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