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

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NCT00636246

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Study Location
Pfizer Investigational Site
Viljandi, Viljandi mk., 71024, Estonia
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Contact
1-800-718-1021
[email protected]
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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2008)		510
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00636246
Other Study ID Numbers  ICMJE A0501075
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP