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 antidepressant therapy.
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Qualified Participants May Receive:
Free medication, free physical exam, and compensation for time and travel.