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

PHASE2CompletedINTERVENTIONAL
Enrollment

510

Participants

Timeline

Start Date

June 30, 2004

Study Completion Date

August 31, 2005

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

Trial Locations (17)

10614

Pfizer Investigational Site, Tallinn

51008

Pfizer Investigational Site, Tartu

71024

Pfizer Investigational Site, Viljandi

80012

Pfizer Investigational Site, Pärnu

107076

Pfizer Investigational Site, Moscow

115522

Pfizer Investigational Site, Moscow

119034

Pfizer Investigational Site, Moscow

127473

Pfizer Investigational Site, Moscow

190121

Pfizer Investigational Site, Saint Petersburg

192019

Pfizer Investigational Site, Saint Petersburg

193167

Pfizer Investigational Site, Saint Petersburg

194214

Pfizer Investigational Site, Saint Petersburg

214019

Pfizer Investigational Site, Smolensk

344010

Pfizer Investigational Site, Rostov-on-Don

420012

Pfizer Investigational Site, Kazan'

634014

Pfizer Investigational Site, Tomsk

Unknown

Pfizer Investigational Site, Moscow

All Listed Sponsors
lead

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

INDUSTRY

NCT00636246 - A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression. | Biotech Hunter | Biotech Hunter