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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 November 12, 2019

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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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Major Depressive Disorder
NCT02548949
All Genders
19+
Years
Multiple Sites
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 SummaryThis 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 DescriptionNot 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 DateNot 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2008

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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