Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MSI Methylation Sciences, Inc.
Age
21–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
