- Outpatients men and women aged 65 years or older.
- Mini Mental State Examination score of 24 or above.
- Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic
and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent
episode, without psychotic features, on study day 1, if depressive symptoms for at
least 30 days prior to screening visit and minimum screening and study day -1
(baseline) scores of 16 on the Hamilton Psychiatric Rating Scale for Depression
(HAM-D17).
- Significant risk of suicide based on clinical judgment, including common suicidal
thoughts, and suicide being considered as a possible solution, even without specific
plans or intention.
- Current (within 12 months of 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 as assessed by the modified Mini International Neuropsychiatric Interview
(MINI). Current (within 12 months of baseline) generalized anxiety disorder, panic
disorder, or social anxiety disorder as assessed by the modified MINI and considered
by the investigator to be primary, causing a higher degree of distress or impairment
than MDD. Presence (within 12 months of baseline) of a clinically important
personality disorder (such as antisocial, schizotypal, histrionic, borderline,
narcissistic). Presence of dementia.
- Depression associated with the presence of an organic mental disorder due to a general
medical condition or a neurologic disorder.
Other exclusion applies.