title: Major depressive disorder with subthreshold hypomania (mixed features): Clinical characteristics of patients entered in a multiregional, placebo-controlled study.
abstract: Major depressive disorder (MDD) associated with subthreshold hypomanic symptoms (mixed features), has been identified as a distinct nosological entity in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). We identified the predominant manic symptoms present at baseline in a multiregional, placebo-controlled trial involving 211 patients with MDD with mixed features (Clinicaltrials.govNCT01421134). Patients with 2 or 3 DSM-5 criteria defined manic symptoms were eligible for the study. At study baseline, increased talkativeness (pressure to keep talking) and flight of ideas (racing thoughts) were endorsed by approximately 65% of patients and a decreased need for sleep was endorsed by 40% of patients. Approximately 60% of patients also endorsed irritability and distractibility at baseline although these symptoms are not generally counted as part of the "mixed" depression diagnosis as they may overlap with criteria for MDD. Thus, five clinical symptoms characterized the manic presentation in the majority of patients diagnosed as having MDD with "mixed" features in this first placebo-controlled trial examining the use of a psychotropic medication (lurasidone) in this population. Our findings support the designation of MDD with mixed features specifier and suggest that this subpopulation of depressed patients may warrant additional medication beyond antidepressants.
authors.affiliation: Bracket Global and Clintara, LLC, Boston, MA, United States. Electronic address: sdtargum@yahoo.com.
authors.forename: Steven D
authors.initials: SD
authors.lastname: Targum
authors.affiliation: Stanford University School of Medicine, Palo Alto, CA, United States.
authors.forename: Trisha
authors.initials: T
authors.lastname: Suppes
authors.affiliation: Bracket Global and Clintara, LLC, Boston, MA, United States.
authors.forename: J Cara
authors.initials: JC
authors.lastname: Pendergrass
authors.affiliation: Bracket Global and Clintara, LLC, Boston, MA, United States.
authors.forename: Sang
authors.initials: S
authors.lastname: Lee
authors.affiliation: Sunovion Pharmaceuticals Inc., Fort Lee, NJ and Marlborough, MA, United States.
authors.forename: Robert
authors.initials: R
authors.lastname: Silva
authors.affiliation: Sunovion Pharmaceuticals Inc., Fort Lee, NJ and Marlborough, MA, United States.
authors.forename: Josephine
authors.initials: J
authors.lastname: Cucchiaro
authors.affiliation: Sunovion Pharmaceuticals Inc., Fort Lee, NJ and Marlborough, MA, United States.
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000145:classification / Q000188:drug therapy / Q000503:physiopathology*; D003865:Major Depressive Disorder / Q000145:classification* / Q000188:drug therapy / Q000503:physiopathology*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006801:Humans; D000069056:Lurasidone Hydrochloride / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic
chemical_list: D014150:Antipsychotic Agents; D000069056:Lurasidone Hydrochloride
keywords: Depression subtypes; Lurasidone; Major depressive disorder; Mixed features specifier; Subthreshold hypomania