title: Use of asenapine as add-on therapy in the treatment of bipolar disorder: a comprehensive review and case series.
abstract: BACKGROUND
  Several randomized controlled trials (RCTs), conducted in schizophrenic and bipolar patients, have documented the efficacy and tolerability of asenapine as monotherapy both for short- and long-term treatment. However, evidence on its augmentative use is more limited and related to the manic/mixed phase of bipolar disorder (BD).
  
  
  METHODS
  The present article reviews augmentative asenapine efficacy and safety/tolerability in the treatment of BD. It also includes some original cases of bipolar patients treated with add-on asenapine in the short- and long-term.
  
  
  CONCLUSIONS
  To date, only a single RCT with manic/mixed patients with partial response to mood-stabilizer monotherapy supports the efficacy and safety/tolerability of augmentative asenapine to lithium/valproate, both in acute and long-term treatment. Additionally, two case reports confirm the overall effectiveness of augmentative asenapine to clozapine and valproate. Our case series, consisting of 4 bipolar patients treated with adjunctive asenapine to mood stabilizers and atypical antipsychotics - with treatment duration ranging from 1 to 14 months - provided clinical results that are consistent with literature data. Taken as a whole, available evidence seems to support the efficacy and safety of adjunctive asenapine in bipolar patients, though additional studies with active comparators are requested to confirm the current body of evidence.
authors.affiliation: Università degli Studi di Milano, Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda, Dipartimento di Fisiopatologia medico-chirurgica e dei trapianti, Dipartimento di Salute Mentale , Via Francesco Sforza 35, Milano , Italy.
authors.forename: Bernardo
authors.initials: B
authors.lastname: Dell'Osso
authors.forename: Laura
authors.initials: L
authors.lastname: Cremaschi
authors.forename: Maria Carlotta
authors.initials: MC
authors.lastname: Palazzo
authors.forename: Gregorio
authors.initials: G
authors.lastname: Spagnolin
authors.forename: Alma
authors.initials: A
authors.lastname: Cattaneo
authors.forename: Benedetta
authors.initials: B
authors.lastname: Grancini
authors.forename: Matteo
authors.initials: M
authors.lastname: Maggi
authors.forename: Alfredo Carlo
authors.initials: AC
authors.lastname: Altamura
mesh_terms: D018692:Antimanic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000503:physiopathology; D003986:Dibenzocycloheptenes; D004359:Drug Therapy, Combination; D005260:Female; D006576:Heterocyclic Compounds, 4 or More Rings / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors
chemical_list: D018692:Antimanic Agents; D014150:Antipsychotic Agents; D003986:Dibenzocycloheptenes; D006576:Heterocyclic Compounds, 4 or More Rings; C522667:asenapine
keywords: add-on therapy; asenapine; bipolar disorder; efficacy; tolerability