Major Depressive Disorder MedDRA version: 11.0 Level: LLT Classification code 10025453 Term:
Conditions
Interventions
Product Code: SSR411298
Pharmaceutical Form: Capsule, hard
CAS Number: 666860-59-9
Current Sponsor code: SSR411298
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatient =60 years of age. 2. Diagnosis of major depressive disorder (MDD) •defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria •confirmed by the Mini International Neuropsychiatric Interview (MINI) •recurrent episode for at least one month prior to Visit 1 •episode may be isolated or superimposed on dysthymic disorder and may meet criteria for atypical or melancholic features •may also meet criteria for anxiety disorder comorbid disorders (such as panic disorder with or without agoraphobia, social phobia or obsessive-compulsive disorder), provided that depression is the predominant disorder in terms of severity and subjective distress. 3. Given written informed consent. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Exclusion criteria related to study methodology 1. Unable to comply with study protocol requirements. 2. HAM-D total score 5 on the suicidal thoughts item of the MADRS (item 10) at screening Visit 1 (Day -7) or baseline Visit 2 (Day -1) •or score of >3 on the suicide item (item 3) of the HAM-D at screening Visit 1 (Day -7) or baseline Visit 2 (Day -1); •or a current suicide risk score =10 from Module C (suicidality) of the MINI. 6. History of a suicide attempt within the past 2 years. 7. Duration of the current depressive episode is greater than 2 years. 8. Current depressive episode has been diagnosed with psychotic features, catatonic features, or seasonal pattern, or is secondary to a general medical condition (DSM-IV-TR 293.83). 9. History or presence of bipolar disorder or psychotic disorder, according to the item D and L of the MINI. 10. Post-traumatic stress disorders, anorexia nervosa and bulimia nervosa within the past 6 months, according to the items I, M and N of the MINI. 11. Meets DSM-IV-TR criteria for Antisocial Personality Disorder or Borderline Personality Disorder. 12. Alcohol dependence or abuse or substance dependence or abuse in the past 12 months, according to the MINI, except nicotine or caffeine dependence. 13. Used the following prior to entry into the Randomized Treatment Phase: a) Any monoamine oxidase inhibitors (MAOIs) within the past 2 weeks, b) Any other antidepressant, antipsychotic, anxiolytic, sedative-hypnotic, or mood stabilizer (lithium, anticonvulsants) within the past 7 days, except permitted concomitant medications as defined in Section 3. 14. Prohibited concomitant treatments as defined in Section 3. 15. Treatment with electroconvulsive therapy (ECT) within the past 1 year. 16. Initiated, stopped, or changed frequency and/or nature of psychotherapy within the past 6 weeks. 17. Tested positive for any illicit drug included in the urine drug screen at Visit 1 (Day-7). 18. Abnormal thyroid function (ie, out of range TSH blood level at Visit 1) unless patients are receiving thyroid replacement therapy at a stable dose for the past 3 months and/or are considered clinically euthyroid. 19. Severe progressive or unstable cardiovascular, renal, hepatic, respiratory, hematological, endocrinological, neurological, or other somatic disease that, according to the Investigator’s judgment, might interfere with the evaluation of study medication. 20. Significantly abnormal hepatic clinical laboratories: ALT, AST, or GGT >3x ULN; Tbili >ULN). 21. Participation in a clinical trial of an experimental therapy within the past 30 days or concomitant use of any FAAH inhibitor. -Exclusion criteria related to escitalopram 21. Clinical history of non-response (4-week treatment at therapeutic dose) or intolerance to escitalopram or citalopram. 22. Hypersensitivity to escitalopram or citalopram or any of the inactive ingredients of the formulation. -Exclusion criteria related to SSR411298 23. Using CYP3A strong inhibitors and inducers within the past 7 days. 24. Females who are not at least one year post-menopausal. (Post-menopausal is defined as the time after which a woman has experienced twelve consecutive months of amenorrhea, and menopausal s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy criterion is the difference between treatment groups in the mean change from baseline to Visit 8 (Day 56) on the 17-item Hamilton Depression Rating Scale (HAM-D).;Main Objective: The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298 (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive Disorder (MDD), based on the 17-item Hamilton Depression Rating Scale (HAM-D).;Secondary Objective: •To evaluate the tolerability and safety of an 8-week treatment with SSR411298 versus placebo in elderly patients with MDD •To evaluate the effect of SSR411298 on disability, anxiety, cognitive function, sleep, and pain and somatic symptoms related to depression, and bone markers •To assess SSR411298 plasma concentrations •To assess plasma endocannabinoid concentrations | — |
Countries
Slovakia
Outcome results
None listed