Status:
COMPLETED
A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety profile of ...
Eligibility Criteria
Inclusion
- Subjects must fulfill the criteria for MDD without psychotic features as defined by DSMIV, based on clinical assessment and confirmed by Structural Clinical Interview for DSM-IV Axis I Disorder-Clinical Version (SCID-I) plus the MDD Specifiers included in the Research Version of SCID-I.
- HAM-D (17-item) ≥ 22 at Screening (Visit 1) and \> 20 at Baseline (Visit 2).
- Minimum CGI-S ≥ 4 at Screening (Visit 1) and at Baseline (Visit 2).
Exclusion
- Known failure to satisfactory respond after adequate dose and duration (12 weeks) of treatment with clomipramine and one SSRI, or with two or more SSRIs.
- Subjects with \> 20% HAM-D (17-item) improvement (decrease) from Screening (Visit 1) at Baseline (Visit 2).
- Subjects with uncorrected hypothyroidism or hyperthyroidism.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT00636246
Start Date
June 1 2004
End Date
August 1 2005
Last Update
January 28 2021
Active Locations (17)
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1
Pfizer Investigational Site
Viljandi, Viljandi Mk., Estonia, 71024
2
Pfizer Investigational Site
Pärnu, Estonia, 80012
3
Pfizer Investigational Site
Tallinn, Estonia, 10614
4
Pfizer Investigational Site
Tartu, Estonia, 51008