Depressive Disorder, Major Clinical Trial
Official title:
Sertraline/[S,S]-Reboxetine Combination Versus Sertraline And [S,S]-Reboxetine Monotherapy In Major Depressive Disorder (MDD) In A Double-Blind, Placebo-Controlled, Eight Week Study.
NCT number | NCT00636246 |
Other study ID # | A0501075 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2004 |
Est. completion date | August 2005 |
Verified date | January 2021 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 SSRIs.
Status | Completed |
Enrollment | 510 |
Est. completion date | August 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Estonia | Pfizer Investigational Site | Pärnu | |
Estonia | Pfizer Investigational Site | Tallinn | |
Estonia | Pfizer Investigational Site | Tartu | |
Estonia | Pfizer Investigational Site | Viljandi | Viljandi Mk. |
Russian Federation | Pfizer Investigational Site | Kazan | |
Russian Federation | Pfizer Investigational Site | Moscow | |
Russian Federation | Pfizer Investigational Site | Moscow | |
Russian Federation | Pfizer Investigational Site | Moscow | |
Russian Federation | Pfizer Investigational Site | Moscow | |
Russian Federation | Pfizer Investigational Site | Moscow | |
Russian Federation | Pfizer Investigational Site | Rostov On Don | |
Russian Federation | Pfizer Investigational Site | Smolensk | |
Russian Federation | Pfizer Investigational Site | St Petersburg | |
Russian Federation | Pfizer Investigational Site | St. Petersburg | |
Russian Federation | Pfizer Investigational Site | St. Petersburg | |
Russian Federation | Pfizer Investigational Site | St. Petersburg | |
Russian Federation | Pfizer Investigational Site | Tomsk |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Estonia, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change from Baseline up to Week 8 (Visit 9) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as measured by a mixed concentration, suicidal ideation and restlessness. | visits 1-9 | ||
Secondary | Change from Baseline in HAM-D (17-item) total score | Weeks 1, 2, 3, 5, 6, and 8 | ||
Secondary | Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES) | Weeks 5 and 8 | ||
Secondary | The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics. | Weeks 1, 2, 3, 5, 6, and 8 | ||
Secondary | Change from Baseline in MADRS total score | Weeks 1, 2, 3, 5, 6, and 8 |
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