Major Depressive Disorder
Conditions
Interventions
Product Name: NA
Product Code: SR58611
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: NA
CAS Number: 121524-09-2
Current Sponsor code: SR58611A
Other descriptive name: NA
Concentration u
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (ages 18 years to 65 years) with Major Depressive Disorder. 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: Exclusion criteria related to study methodology 1. Is unable/unwilling to volunteer informed consent to participate in the study, or 2. Is unable/unwilling to participate in or follow the procedures required by the study through the last scheduled visit, or 3. Following psychiatric evaluation, the patient does not have a diagnosis of Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) -- Text Revision (DSM-IV-TR) (3), or 4. Does not meet criteria for a recurrent Major Depressive Episode (MDE) according to DSM-IV-TR and M.I.N.I. International Neuropsychiatric Interview (MINI) (4) for at least 1 month but no more than 2 years, or 5. Does not present with a Montgomery-Asberg Depression Rating Scale (MADRS) (5) total score =30, or 6. Patient has a psychiatric diagnosis that could interfere with evaluation of the investigational product; 7. Patient is at immediate risk for suicidal behavior based on an unstructured clinical interview; or has: - A score of >5 on the suicidal thoughts item of the MADRS, or - A score of 4 on the suicide item of the Hamilton Depression Rating Scale, or - A current suicide risk score = 10 from module C of the MINI, or 8. Patient has taken, or requires, or is expected to require within 2 weeks of the date of randomization, concomitant treatment that may interfere with valid collection or interpretation of study data 9. Patient has been treated with electroconvulsive or other non-pharmacologic biological therapy (e.g., phototherapy), or effective psychotherapy in the past 6 months, or 10. Patient presents with evidence (e.g., positive results from a urine drug screen, observation, interview) during the screening period of illegal or covert drug use, or 11. During the screening period, patient presents with a current or past history, physical signs, clinical laboratory, or electrocardiogram (ECG) evidence of a clinically significant or unstable medical, neurological, surgical, obstetrical or congenital condition that may, in the Investigator’s medical judgment, interfere with valid collection or interpretation of efficacy or safety data, or 12. Patient is at risk for clinical deterioration, anaphylaxis, a withdrawal syndrome, residual effects, serotonin toxicity or drug interaction as a consequence of prior, current, or abrupt discontinuation of pharmacologic treatment, or 13. Patient is pregnant (based on pregnancy test, history, or physical exam) or breastfeeding, or likely to become pregnant during the course of the study, or 14. Patient is unwilling or unable to be tested for pregnancy (if pregnancy is a possibility during the study), or unwilling or unable to properly use an effective method of pregnancy prevention (e.g., hormonal contraception, intrauterine device, physical barrier plus spermicide). Exclusion criteria related to escitalopram 15. Patient has been treated with escitalopram within the previous 6 months, or 16. Patient has a history of untoward reaction possibly related to prior treatment with escitalopram (e.g., history of serotonin toxicity) that may interfere with adherence during the study, or 17. Patient with hypersensitivity to escitalopram or to any of the excipients (e.g., microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium, magnesium stearate, hypromellose, Macrogol 400, titanium dioxide [E 171]), or 18. Patient requires, or is expected to require concomitant treatment with non-selective, irrevers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare, after 8 weeks, the efficacy of the SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with Escitalopram 10 mg/d.;Secondary Objective: The secondary objective of this study is to document clinical safety and tolerability of the association of SR58611A versus placebo both on concomitant treatment with escitalopram 10 mg/d.;Primary end point(s): The primary efficacy criterion is the difference observed between Group 1 vs. Group 2 on mean change from baseline to V8 (D56) in the 17-item HAM-D total score. | — |
Countries
Estonia, Finland, Germany, Greece
Outcome results
None listed