Status:
COMPLETED
Add-On Study of MSI-195 (S-Adenosyl-L-Methionine, SAMe) for Patients With Major Depressive Disorder (MDD)
Lead Sponsor:
MSI Methylation Sciences, Inc.
Conditions:
Major Depressive Disorder (MDD)
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy and safety of 800 mg MSI-195 in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current an...
Eligibility Criteria
Inclusion
- Meets the Diagnostic and Statistical Manual of Mental Disorder, 4th Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
- A total score of 16 or higher on the Hamilton Rating Scale for Depression- 17 item version (HAM-D17) at the Screening and Baseline Visits, with a score of ≥2 on mood item 1.
- Have experienced 1-4 prior Major Depressive Episodes. Patients with more than 5 lifetime episodes (including current episode) will require discussion with the medical monitor prior to inclusion.
- Failed 1-3 treatment regimens in the current depressive episode
- Received an adequate dose and duration of Antidepressant Therapy (ADT) (on ADT for at least 6 weeks with a stable dose for at least 3 weeks)
Exclusion
- Failed 4 or more adequate treatment regimens in current episode of depression
- patient may have a significant risk for suicidal behavior during the course of their participation in the study
- Intolerance to SAMe; Prior use of MSI-195
- History of any of the following psychiatric disorders: eating disorder within 6 months; obsessive compulsive disorder, psychotic disorder, bipolar disorder, mental retardation, dementia or other forms of cognitive impairment at any time or alcohol or substance abuse
- \>3X upper limit of normal (ULN) Alkaline Phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT); \>1.5X ULN total bilirubin
- Pregnant or lactating women
- Any history of seizures, excluding febrile seizures
- Known positivity for human immunodeficiency virus
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT01912196
Start Date
October 1 2013
End Date
September 1 2015
Last Update
March 18 2016
Active Locations (35)
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1
MSI Investigational Site
Birmingham, Alabama, United States, 35216
2
MSI Investigational Site
Encino, California, United States, 91316
3
MSI Investigational Site
Escondido, California, United States, 92025
4
MSI Investigational Site
Garden Grove, California, United States, 92845