A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.
NCT ID: NCT00636246
Last Updated: 2021-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
510 participants
INTERVENTIONAL
2004-06-30
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sertraline/[S,S]-Reboxetine-satellite150/4
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.
Sertraline/[S,S]-Reboxetine-satellite150/6
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.
sertraline-satellite
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.
sertraline-main
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
Sertraline/[S,S]-Reboxetine-satellite150/2
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.
Placebo
Placebo
Tablets, orally once per day for 8 weeks
Sertraline/[S,S]-Reboxetine-main
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
[S,S]-reboxetine-main
[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
Interventions
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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.
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.
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.
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
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.
Placebo
Tablets, orally once per day for 8 weeks
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
[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
Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects with \> 20% HAM-D (17-item) improvement (decrease) from Screening (Visit 1) at Baseline (Visit 2).
* Subjects with uncorrected hypothyroidism or hyperthyroidism.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Viljandi, Viljandi Mk., Estonia
Pfizer Investigational Site
Pärnu, , Estonia
Pfizer Investigational Site
Tallinn, , Estonia
Pfizer Investigational Site
Tartu, , Estonia
Pfizer Investigational Site
Kazan', , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Rostov-on-Don, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Smolensk, , Russia
Pfizer Investigational Site
Tomsk, , Russia
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0501075
Identifier Type: -
Identifier Source: org_study_id
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