Major Depression Disorder 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 COMPRESSE GASTRORESISTENTI20 COMPRESSE
Product Name: Samyr
Product Code: [NA]
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: S ADENOSIL L METIONINA 1,4 BU
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) and as confirmed by version 7.0 of the Mini International Neuropsychiatric Interview (MINI). 5. Subject is on prescribed SSRI (citalopram / escitalopram / sertraline / paroxetine / fluoxetine) or SNRI (venlafaxine / desvenlafaxine / duloxetine) antidepressant treatment, at approved and stable dose, for at least 4 weeks prior to screening that is insufficient/ineffective. 6. The subject is deemed to have inadequate response (less than 50% symptom reduction) to their current antidepressant based on the investigator judgment and the treatment history. 7. Subject who have a HDRS-17 score between 15-20 at screening. The baseline score must remain =20 and should not have >10% reduction between screening and baseline (randomization visit). 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 600 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject must not be enrolled in the study if they meet any of the following 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. Any lifetime history of bipolar disorders or psychotic disorders (other than MDD with psychotic features in a prior but not the current episode) as per the MINI. 6. History of drug abuse and/or marijuana use and/or alcohol dependence during the 3 years prior to screening. 7. The subject is, in the investigator’s opinion, at significant current risk of harming himself/herself, or provides the following answers on the C-SSRS at screening: • “Yes” to Question 4 or 5 on the Lifetime version Suicidal Ideation section and the ideation was within the last 3 months at Screening Visit, OR • “Yes” to question on the Lifetime version Suicidal Behavior section (other than preparatory behavior) and the ideation was within the last 3 months at Screening Visit. 8. Use of more than any 4 acceptable antidepressant treatments since the diagnosis of depression. 9. Previous treatment with Samyr which was not effective or resulted in an AE, or already treated with Samyr for the current episode. 10. Hypersensitivity to the active substance or to any of the excipients of Samyr or placebo (lactose). 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 during the 4 weeks prior to screening; these must not be taken during study. 14. Treatment with prohibit medication prior to screening as detailed in Appendix 1. 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. Currently 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. Female subjects who are pregnant or breast-feeding or are planning to become pregnant during the study. 20. 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 in subjects with MDD with inadequate response to antidepressants and Hamilton score of 15-20 (with up to 10% reduction at baseline) Samyr® is superior to placebo tablet, when used along with an adjunctive antidepressant therapy following six weeks of treatment based on HDRS-17 score;Secondary Objective: Secondary objective: To evaluate the general improvement on the Patient Global Impression (PGI) scale and the Clinical Global Impression (CGI) scale following six weeks of treatment. Safety objective: To evaluate the safety and tolerability of Samyr® tablet;Primary end point(s): Change from baseline in the HDRS-17 score after 6 weeks of treatment (visit 9);Timepoint(s) of evaluation of this end point: After 6 weeks of treatment (visit 9) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline of the PGI and CGI scales after 6 weeks of treatment (visit 9);Timepoint(s) of evaluation of this end point: After 6 weeks of treatment (visit 9) | — |
Countries
Italy
Contacts
Public ContactMelanie Emmeluth
Meda Pharma GmbH & Co. KG
Outcome results
None listed