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

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
sertraline/[S,S]-reboxetine
sertraline/[S,S]-reboxetine
sertraline
sertraline
sertraline/[S,S]-reboxetine
Placebo
sertraline/[S,S]-reboxetine
[S,S]-reboxetine monotherapy
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Experimental

Placebo Comparator

Experimental

Active Comparator

Arm Label

Sertraline/[S,S]-Reboxetine-satellite150/4

Sertraline/[S,S]-Reboxetine-satellite150/6

sertraline-satellite

sertraline-main

Sertraline/[S,S]-Reboxetine-satellite150/2

Placebo

Sertraline/[S,S]-Reboxetine-main

[S,S]-reboxetine-main

Arm Description

Outcomes

Primary Outcome 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.

Secondary Outcome Measures

Change from Baseline in HAM-D (17-item) total score
Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES)
The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics.
Change from Baseline in MADRS total score

Full Information

First Posted
March 7, 2008
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00636246
Brief Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
510 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sertraline/[S,S]-Reboxetine-satellite150/4
Arm Type
Experimental
Arm Title
Sertraline/[S,S]-Reboxetine-satellite150/6
Arm Type
Experimental
Arm Title
sertraline-satellite
Arm Type
Active Comparator
Arm Title
sertraline-main
Arm Type
Active Comparator
Arm Title
Sertraline/[S,S]-Reboxetine-satellite150/2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Sertraline/[S,S]-Reboxetine-main
Arm Type
Experimental
Arm Title
[S,S]-reboxetine-main
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
sertraline/[S,S]-reboxetine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
sertraline/[S,S]-reboxetine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
sertraline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
sertraline
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
sertraline/[S,S]-reboxetine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, orally once per day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
sertraline/[S,S]-reboxetine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
[S,S]-reboxetine monotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from Baseline in HAM-D (17-item) total score
Time Frame
Weeks 1, 2, 3, 5, 6, and 8
Title
Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES)
Time Frame
Weeks 5 and 8
Title
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
Title
Change from Baseline in MADRS total score
Time Frame
Weeks 1, 2, 3, 5, 6, and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Viljandi
State/Province
Viljandi Mk.
ZIP/Postal Code
71024
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Pärnu
ZIP/Postal Code
80012
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tallinn
ZIP/Postal Code
10614
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tartu
ZIP/Postal Code
51008
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
119034
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Rostov On Don
ZIP/Postal Code
344010
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
194214
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0501075&StudyName=A%20comparison%20of%20sertaline-reboxetine%20combination%20therapy%20versus%20sertaline%20or%20reboxatine%20monotherapy%20in%20the%20treatment%20of%20major%20depression.
Description
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A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.

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