NCT00636246

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-06-01
• Completion: 2005-08-01
• First posted: 2008-03-14
• Last updated: 2021-01-28

Locations

17 sites across 2 countries: Estonia, Russia