A Safety, Efficacy and Tolerability Study of SEP-225289

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depression, Mental Disorders, Mood Disorders, Depressive Disorder, Major, Dysthymic Disorder Read More

Inclusion Criteria:

• The duration of the current episode must be at least 1 month but not longer than 12 months.
• Subjects must have a primary diagnosis of Major Depressive Disorder.
• Subjects must have had at least one previous, diagnosed episode of MDD in the past 5 years.
• MDD must be the condition that was chiefly responsible for motivating the subject to seek treatment.
• Subject is in general good health.

Exclusion Criteria:

• Subject is participating in, has participated in, or plans to participate in any investigational drug study.
• Subject who has donated blood within the last 30 days or plans to donate blood during and 30 days following participation.
• Known failure to respond (in the past 5 years) to two adequate (dose and duration) antidepressant medications with distance mechanisms of action including tricyclics.
• Subjects who have undergone Electroconvulsive Therapy treatment.
• Treatment with fluoxetine, in the 6 weeks before baseline.
• Subject with psychotic disorders, anorexia nervosa, bulimia or post-traumatic stress disorder.
• Subject with a history or presence of bipolar disorder (i.e., current or past history of manic episode).
• Subjects with Obsessive Compulsive Disorder.
• Subjects with a lifetime diagnosis of Panic Disorder.
• Subject received treatment with antidepressants within 2 weeks.
• Subject with lifetime history of suicidal attempts, alcohol dependence or abuse, drug(s) dependence or abuse (excluding nicotine and caffeine) or has a positive urine drug screen.
• Subject has a history of significant risk of suicide or homicide.
• Bereavement - Defined as death of a loved one within 3 months.
• Subject has a documented history of HIV, hepatitis B or hepatitis C.