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Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score. [ Time Frame: 10 Weeks ]
Secondary Outcome Measures
Mean change from baseline in HAM-D item 1; Mean change from baseline in the CGI severity of illness score at study endpoint; Percentage of patients with HAM-D total score less than or equal to 7. [ Time Frame: 10 Weeks ]
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Ages Eligible for Study:
60 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of Major Depressive Disorder (MDD).
Current major depressive episode at screen at least 2 months duration.
Must be at least 60 years of age.
Patients with a primary diagnosis other than MDD.
Patients with a history of schizophrenia, schizoaffective disorder, bipolar disorder or dementia.
Patients with a history of brief depressive episodes lasting less than 8 weeks.
Patients receiving formal psychotherapy within 12 weeks of study.
Patients who are suicidal.
Patients who have received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening.
Pitts CD, Schaefer D, Lipschitz A, Iyengar M: Efficacy and Tolerability of Fixed, Low Dose Paroxetine CR in the Treatment of Depression in the Elderly, Poster No. NR701, presented at the American Psychiatric Association Annual Meeting, May 2005. Available at: www.psych.org