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

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

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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-06-30

Completion

2005-08-31

Countries

• Estonia
• Russia

Study Locations