Major Depression Disorders MedDRA version: 21.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: SAMYR - 400 MG/5 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 5 FLACONCINI POLVERE + 5 FIALE SOLVENTE 5 ML
Product Name: SAMYR
Product Code: SAMYR
Pharmaceutical Form: Powder and solven
Sponsors
MYLAN INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all the following inclusion criteria to be eligible for enrolment into the study: 1. Written and signed informed consent needs to be provided by subject before starting any protocol-specific procedures. 2. Male and female subject between the ages of 18 to 65 years, both ages inclusive. 3. Subject who is able and willing to comply with the requirements of the study protocol including the visits scheme, assessments and scales. 4. Primary diagnosis of MDD of at least 12 weeks duration, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), criteria. 5. Subject is on prescribed SSRI (citalopram / escitalopram / sertraline / paroxetine) or SNRI (venlafaxine / duloxetine) antidepressant treatment, at approved and stable dose (based on local SmPC), for at least 4 weeks prior to screening. 6. Partial-response to the prescribed antidepressant during the last 8 weeks prior to screening. Partial response is defined as less than 50% symptom reduction. 7. Subject who have a Montgomery-Asberg Depression Rating Scale (MADRS) score as assessed by the site investigator of at least 22 at screening and with less than 15% reduction at baseline, post run in treatment. 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 468 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History or presence of a medical condition or disease that in the Investigator’s opinion would place the subject at an unacceptable risk as a result of trial participation. 2. Any clinically significant abnormality in electrocardiogram (ECG) or safety laboratory tests that in the Investigator’s opinion would place the subject at an unacceptable risk as a result of trial participation. 3. Receipt of another investigational drug within 45 days prior to screening, or if the screening visit is within 5 half-lives of another investigational drug received (whichever is longer), or scheduled to receive another investigational drug during the current study period. 4. Any elective surgery requiring hospitalization planned during the study period. 5. History of bipolar disorders, Schizophrenia and other psychotic disorders. 6. Substance abuse or dependence. 7. Previous suicidal planning or suicide attempt. 8. Use of more than 4 acceptable antidepressant treatments since the diagnosis of depression or treatment with ECT or ketamine during the current episode or lifetime treatment with Vagus Nerve Stimulation (VNS) during the last 5 years. 9. Previous treatment with Samyr which was not effective or resulted in an AE, or already treated with Samyr during the current episode. 10. Hypersensitivity to the active substance or to any of the excipients of Samyr. 11. Subjects with known genetic defects which affect the methionine cycle and/or cause homocystinuria and/or hyperhomocysteinaemia (e.g. cystathionine beta-synthase deficiency, defects of vitamin B12 metabolism). 12. Treatment with Monoamine Oxidase (MAO)-inhibitors including selegiline and moclobemide, during the 4 weeks prior to screening. 13. Treatment with linezolid or pimozide. 14. Treatment with at least one prohibited medication as detailed in Appendix 1 (prohibit drug medication prior and during the study). 15. Cardiac disorder which in the Investigator’s opinion would place the subject at an unacceptable risk from trial participation. 16. Known QT interval prolongation or congenital long QT syndrome. 17. Treatment with products that are known to prolong the QT interval. 18. Hepatic values that in the Investigator’s opinion would place the subject at an unacceptable risk as a result of trial participation. 19. Subject did not pass the remote assessment with MGH CTNI rater. 20. Decrease in the baseline MADRS score by = 15% vs screening visit. 21. Female subjects who are pregnant or plan to be pregnant or breast feeding. 22. Female subjects of childbearing potential who are not able/willing to use oral contraception or acceptable methods of contraception as outlined in this protocol (Section 4.3), from the time of screening and for the duration of the study, through study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that Samyr IM is superior to placebo IM as an enhancer adjunctive to antidepressant therapy. The primary endpoint is the change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) for Depression score after 7 days (visit 13) of treatment. ;Secondary Objective: To compare mean change from baseline to day 14 (visit 20) for MADRS, Hamilton Depression Rating Scale (HDRS)-6, Patient Global Impression (PGI) scale and Clinical Global Impression (CGI) scale between the 2 treatments. To evaluate the safety and tolerability of Samyr IM. ;Primary end point(s): Change from baseline in the MADRS score after 7 days of treatment (visit 13);Timepoint(s) of evaluation of this end point: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in the MADRS score after 14 days of treatment (visit 20); Change from baseline of the HDRS-6, PGI and CGI scales after 7 and 14 days of treatment (visits 13 and 20);Timepoint(s) of evaluation of this end point: after 14 days; after 7 and 14 days of treatment | — |
Countries
Italy
Contacts
Public ContactDavid Gillogly
Mylan Inc
Outcome results
None listed