A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.

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.”

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.

Intervention(s) in this Clinical Trial

• Drug: sertraline/[S,S]-reboxetine
  • Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg [S,S]-reboxetine for 5 and one half weeks.
• Drug: sertraline/[S,S]-reboxetine
  • Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/6mg [S,S]-reboxetine for 5 and one half weeks.
• Drug: sertraline
  • Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks.
• Drug: sertraline
  • Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks
• Drug: sertraline/[S,S]-reboxetine
  • Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks.
• Drug: Placebo
  • Tablets, orally once per day for 8 weeks
• Drug: sertraline/[S,S]-reboxetine
  • Tablets, 50mg sertraline/2mg [S,S]-reboxetine orally for 3 days, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks
• Drug: [S,S]-reboxetine monotherapy
  • Tablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Sertraline/[S,S]-Reboxetine-satellite150/4
• Experimental: Sertraline/[S,S]-Reboxetine-satellite150/6
• Active Comparator: sertraline-satellite
• Active Comparator: sertraline-main
• Experimental: Sertraline/[S,S]-Reboxetine-satellite150/2
• Placebo Comparator: Placebo
• Experimental: Sertraline/[S,S]-Reboxetine-main
• Active Comparator: [S,S]-reboxetine-main

Primary Measures

• 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.
  • Time Frame: visits 1-9
    Safety Issue?: No

Secondary Measures

• Change from Baseline in HAM-D (17-item) total score
  • Time Frame: Weeks 1, 2, 3, 5, 6, and 8
    Safety Issue?: Yes
• Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES)
  • Time Frame: Weeks 5 and 8
    Safety Issue?: Yes
• The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics.
  • Time Frame: Weeks 1, 2, 3, 5, 6, and 8
    Safety Issue?: No
• Change from Baseline in MADRS total score
  • Time Frame: Weeks 1, 2, 3, 5, 6, and 8
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00636246

Study ID Number: A0501075

ClinicalTrials.gov Identifier: NCT00636246

Health Authority: Russia: Ministry of Health, Department of State Quality, Efficacy and Safety Control of Medicines and Medical Technics.

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