- A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without
- Depressive symptoms for at least 30 days before the screening visit.
- Outpatient men and women at least 18 years of age.
- Significant risk of suicide based on clinical judgment, including common suicidal
thoughts and suicide having been considered as a possible solution even without
specific plans or intent.
- Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled
hypertension), ophthalmologic, neurologic, or any other medical condition that might
confound the study or put the subject at greater risk during study participation.
- Current (within 12 months before baseline) psychoactive substance abuse or dependence
(including alcohol), manic episode, posttraumatic stress disorder,
obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic
disorder; b) current (within 12 months before baseline) generalized anxiety disorder,
panic disorder, or social anxiety disorder; c) presence (within 12 months before
baseline) of a clinically important personality disorder as assessed during the