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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Viljandi, Viljandi mk., 71024 Estonia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00636246
Pfizer
Completed
A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.

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A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Depressive Disorder, Major
  • 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
  • Experimental: Sertraline/[S,S]-Reboxetine-satellite150/4
    Intervention: Drug: sertraline/[S,S]-reboxetine
  • Experimental: Sertraline/[S,S]-Reboxetine-satellite150/6
    Intervention: Drug: sertraline/[S,S]-reboxetine
  • Active Comparator: sertraline-satellite
    Intervention: Drug: sertraline
  • Active Comparator: sertraline-main
    Intervention: Drug: sertraline
  • Experimental: Sertraline/[S,S]-Reboxetine-satellite150/2
    Intervention: Drug: sertraline/[S,S]-reboxetine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Sertraline/[S,S]-Reboxetine-main
    Intervention: Drug: sertraline/[S,S]-reboxetine
  • Active Comparator: [S,S]-reboxetine-main
    Intervention: Drug: [S,S]-reboxetine monotherapy
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
510
August 2005
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Estonia,   Russian Federation
 
 
NCT00636246
A0501075
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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