A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.
Phase 2
Completed
- Conditions
- Depressive Disorder, Major
- Interventions
- Registration Number
- NCT00636246
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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 SSRIs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 510
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sertraline/[S,S]-Reboxetine-satellite150/2 sertraline/[S,S]-reboxetine - Sertraline/[S,S]-Reboxetine-satellite150/4 sertraline/[S,S]-reboxetine - Sertraline/[S,S]-Reboxetine-satellite150/6 sertraline/[S,S]-reboxetine - Placebo Placebo - Sertraline/[S,S]-Reboxetine-main sertraline/[S,S]-reboxetine - [S,S]-reboxetine-main [S,S]-reboxetine monotherapy - sertraline-main sertraline - sertraline-satellite sertraline -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change from Baseline in HAM-D (17-item) total score Weeks 1, 2, 3, 5, 6, and 8 Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES) Weeks 5 and 8 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 Change from Baseline in MADRS total score Weeks 1, 2, 3, 5, 6, and 8
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇷🇺Tomsk, Russian Federation