A multi-national, multi-center, double blind, placebo-controlled, parallel group, fixed dose efficacy and safety study of SR58611A 350 mg twice daily vs. placebo in adults with Major Depressive Disorder on concomitant treatment with escitalopram 10 mg/d - ALBERIO

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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