EUCTR2007-003159-36-FI
Active, not recruiting
Not Applicable
An eight-week, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily in patients with major depressive disorder
DrugsCipralex
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- sanofi-aventis recherche & développement
- Enrollment
- 615
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients.
- •2\. 18 to 65 years of age.
- •3\. Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM\-IV\-TR) criteria (296\.3\) and confirmed by the semi\-structured Mini International Neuropsychiatric Interview (MINI).
- •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
- •\- Montgomery\-Asberg Depression Rating Scale (MADRS) total score of less than 24 (\<24\) at Visit 1 (Day –7\) or Visit 2 (Day –1\).
- •\- 17\-item HAM\-D total score of less than 18 (\<18\) at Visit 1 (Day –7\) or Visit 2 (Day –1\)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
An eight-week, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily in patients with major depressive disorderEUCTR2007-003159-36-FRsanofi-aventis recherche & développement675
Active, not recruiting
Not Applicable
An eight-week, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily in patients with major depressive disorderEUCTR2007-003159-36-SEsanofi-aventis recherche & développement615
Active, not recruiting
Not Applicable
An eight-week, double-blind, placebo-controlled, multicenter study with paroxetine (20 mg q24) as positive control, evaluating the efficacy, safety and tolerability of a fixed dose of SR58611A (350 mg q12) in outpatients with Generalized Anxiety Disorder. - NAEUCTR2005-003181-41-SEsanofi-aventis recherche & développement360
Active, not recruiting
Not Applicable
An eight-week, double-blind, placebo-controlled, multicenter study with paroxetine (20 mg q24) as positive control, evaluating the efficacy, safety and tolerability of a fixed dose of SR58611A (350 mg q12) in outpatients with Generalized Anxiety Disorder. - NAGeneralized Anxiety Disorder (GAD)MedDRA version: 8.0Level: LLTClassification code 10018105EUCTR2005-003181-41-EEsanofi-aventis recherche & développement360
Active, not recruiting
Not Applicable
An eight-week, double-blind, placebo-controlled, multicenter study with paroxetine (20 mg q24) as positive control, evaluating the efficacy, safety and tolerability of a fixed dose of SR58611A (350 mg q12) in outpatients with Generalized Anxiety Disorder. - NAGeneralized Anxiety Disorder (GAD)MedDRA version: 8.0Level: LLTClassification code 10018105EUCTR2005-003181-41-ATSanofi-Synthelabo Recherche360