Future Options Research, LLC
The purpose of this study is to evaluate whether or not adding lumateparone to current antidepressant treatment in adults with major depressive disorder experiencing blunted emotion will reduce or eliminate the blunted emotion as rated by the Oxford Depression Questionnaire.
Adults with Major Depressive Disorder who report blunted emotion that is evidenced by responses on the Oxford Depression Questionnaire will add lumateparone to their current treatment once daily for 8 weeks. Primary endpoint will be change fom baseline to week 8 on the Oxford Depression Questionnaire (ODQ). Secondary endpoints will be change from baseline to week 8 on CGI-I and CGI-S as well as change from baseline to week 8 on quality of life as measured by Q-LES-Q-SF.
Inclusion Criteria: Diagnosis of major depressive disorder documented in the medical record and confirmed through evaluation by the Principal Investigator using the M.I.N.I., Oxford Depression Questionnaire score of \> 50 (substantial emotional blunting), Response of "yes" to the "gold standard" standardized screening question on emotional blunting developed by Price et al(2012): "Emotional effects vary, but may include, for example, feelingemotionally 'numbed' or 'blunted' in some way; lacking positive emotions or negative emotions; feeling detached from the world around you; or 'just not…
lumateparone 42 mg once daily added to current antidepressant treatment
Lumateparone
Arctuva estimate
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