An eight-week, double-blind study to evaluate the efficacy, safety, and tolerability of two fixed doses of saredutant (100 mg and 30 mg) once daily in combination with paroxetine 20 mg once daily compared to saredutant placebo in combination with paroxetine 20 mg once daily in patients with major depressive disorder - COMPASS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003863-31-DE

Enrollment

820

Registered

2008-01-14

Start date

2008-04-25

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder MedDRA version: 9.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS

Interventions

Product Name: saredutant succinate Product Code: SR48968C Pharmaceutical Form: Capsule, hard INN or Proposed INN: saredutant succinate CAS Number: 176381-98-9 Current Sponsor code: SR48968C Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female outpatients - 18 to 65 years of age - Diagnosis of major depressive disorder, recurrent episode, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria, recurrent episode, and confirmed by the Mini International Neuropsychiatric Interview (MINI) criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Montgomery-Asberg Depression Rating Scale (MADRS) total score <24 - 17-item HAM-D total score of <18

Design outcomes

Primary

Measure	Time frame
Secondary Objective: - To evaluate the tolerability and safety of two fixed doses of saredutant (100 mg and 30 mg) once daily in combination with paroxetine 20 mg once daily in patients with major depressive disorder;Primary end point(s): - The change from baseline Visit 2 (Day -1) to Visit 7 (Day 56) in the 17-item HAM-D total score in the intent-to-treat (ITT) population - The change from baseline Visit 2 (Day -1) to Visit 7 (Day 56) in the CSFQ total score in the ITT population;Main Objective: - To evaluate the efficacy of two fixed doses of saredutant (100 mg and 30 mg) once daily in combination with paroxetine 20 mg once daily compared to saredutant placebo in combination with paroxetine 20 mg once daily in patients with major depressive disorder, as assessed by the change from baseline Visit 2 (Day –1) to visit 7 (Day 56) in the 17-item Hamilton Depression Rating Scale (HAM-D) total score - To evaluate the effect of two fixed doses of saredutant (100 mg and 30 mg) once daily in combination with paroxetine 20 mg once daily compared to saredutant placebo in combination with paroxetine 20 mg once daily on sexual function in patients with major depressive disorder, as assessed by the change from baseline Visit 2 (Day -1) to Visit 7 (Day 56) in the Changes in Sexual Functioning Questionnaire (CSFQ) total score	—

Measure

Time frame

Secondary Objective: - To evaluate the tolerability and safety of two fixed doses of saredutant (100 mg and 30 mg) once daily in combination with paroxetine 20 mg once daily in patients with major depressive disorder;Primary end point(s): - The change from baseline Visit 2 (Day -1) to Visit 7 (Day 56) in the 17-item HAM-D total score in the intent-to-treat (ITT) population - The change from baseline Visit 2 (Day -1) to Visit 7 (Day 56) in the CSFQ total score in the ITT population;Main Objective: - To evaluate the efficacy of two fixed doses of saredutant (100 mg and 30 mg) once daily in combination with paroxetine 20 mg once daily compared to saredutant placebo in combination with paroxetine 20 mg once daily in patients with major depressive disorder, as assessed by the change from baseline Visit 2 (Day –1) to visit 7 (Day 56) in the 17-item Hamilton Depression Rating Scale (HAM-D) total score - To evaluate the effect of two fixed doses of saredutant (100 mg and 30 mg) once daily in combination with paroxetine 20 mg once daily compared to saredutant placebo in combination with paroxetine 20 mg once daily on sexual function in patients with major depressive disorder, as assessed by the change from baseline Visit 2 (Day -1) to Visit 7 (Day 56) in the Changes in Sexual Functioning Questionnaire (CSFQ) total score

—

Countries

Estonia, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026