An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder (COMPASS)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: placebo; Drug: saredutant (SR48968); Drug: paroxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00629551

EFC10438

EudraCT 2007-003863-31

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).

Enrollment: 825 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients with recurrent Major Depressive Disorder

Exclusion criteria

• Symptoms of current depressive episode for less than 30 days or more than 2 years
• Mild depression, as measured by standard clinical research scales
• Significant suicide risk
• Lack of sexual activity (including masturbation)
• Other psychiatric conditions that would obscure the results of the study
• History of failure to respond to antidepressant treatment
• Pregnancy or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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825 participants in 4 patient groups, including a placebo group

Saredutant 100mg and Paroxetine 20 mg

Experimental group

Description:

combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks

Treatment:

Drug: paroxetine

Drug: saredutant (SR48968)

Saredutant 30mg and Paroxetine 20mg

Experimental group

Description:

combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks

Treatment:

Drug: paroxetine

Drug: saredutant (SR48968)

Paroxetine 20 mg and saredutant placebo

Active Comparator group

Description:

paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks

Treatment:

Drug: paroxetine

Drug: placebo

Placebo

Placebo Comparator group

Description:

Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase

Treatment:

Drug: placebo