Major Depressive Disorder Without Psychotic Features Clinical Trial
Official title:
A Randomized, Blinded, Comparison of Asenapine and Placebo as Adjunctive Treatment in Patients With Non-Psychotic Major Depressive Disorder Incompletely Responsive to Antidepressant Monotherapy
This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing
antidepressant treatment in patients with major depression who have not had a complete
therapeutic response to treatment with the antidepressant alone.
The investigators hypothesize that added asenapine will produce greater reductions in
depression than will added placebo.
The investigators will undertake a 6-week, double-blind, randomized, parallel-group, placebo-controlled trial of adjunctive asenapine in 130 patients with MDD without psychosis who have had an incomplete therapeutic response to treatment with an antidepressant medication alone. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment