title: Does the efficacy of asenapine in bipolar disorder increase in the presence of comorbidity with a substance use disorder? A naturalistic study.
abstract: BACKGROUND
  Asenapine is a second-generation antipsychotic approved in Europe for treating moderate-to-severe manic episodes in adults affected by type I bipolar disorder (BD-I). We aimed to compare its efficacy in psychiatric inpatients with BD-I, with or without substance use disorder (SUD).
  
  
  METHODS
  We administered flexible asenapine doses ranging from 5-20 mg/day to 119 voluntarily hospitalized patients with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) BD-I diagnosis, with or without SUD. Patients were assessed with clinician-rated questionnaires [i.e. Brief Psychiatric Rating Scale (BPRS), Young Mania Rating Scale (YMRS), Hamilton Depression Rating Scale (HDRS), Hamilton Anxiety Rating Scale (HARS), and Global Assessment of Functioning (GAF)]. Assessments were carried out at baseline (T0, prior to treatment), and 3 (T1), 7 (T2), 15 (T3), and 30 days (T4) after starting treatment for all clinical scales and at T0 and T4 for the GAF.
  
  
  RESULTS
  Patients improved on all scales (p< 0.001) across all timepoints, as shown both by paired-sample comparisons and by applying a repeated-measures, generalized linear model (GLM). Patients without comorbid SUD showed greater reductions in BPRS scores at T2 and T3, greater reduction in YMRS scores at T3, and lower HARS scores at all timepoints. HDRS scores did not differ between the two groups at any timepoint. However, the reduction in HARS scores in the comorbid group was stronger than in the BD-I only group, albeit not significantly. Side effects were few and mild-to-moderate.
  
  
  CONCLUSIONS
  The open-label design and the relatively short observation period may expose to both type I and type II statistical errors (false positive and false negatives). Asenapine showed effectiveness and safety in hospitalized BD-I patients. Its effect was stronger in patients without comorbid SUD.
authors.affiliation: Villa von Siebenthal, Genzano di Roma, Italy Department of Neurosciences, Mental Health, and Sensory Organs (NESMOS), School of Medicine and Psychology, Sapienza University, Rome, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: De Filippis
authors.affiliation: Villa von Siebenthal Neuropsychiatric Clinic, Genzano di Roma, Via della Madonnina 1, 00045 Genzano di Roma, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Cuomo
authors.affiliation: Department of Neurosciences, Mental Health, and Sensory Organs (NESMOS), School of Medicine and Psychology, Sapienza University, Rome, Italy.
authors.forename: Georgios D
authors.initials: GD
authors.lastname: Kotzalidis
authors.affiliation: Department of Neurosciences, Mental Health, and Sensory Organs (NESMOS), School of Medicine and Psychology, Sapienza University, Rome, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Pucci
authors.affiliation: Villa von Siebenthal, Genzano di Roma, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Zingaretti
authors.affiliation: Villa von Siebenthal, Genzano di Roma, Italy.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Porrari
authors.affiliation: Villa von Siebenthal, Genzano di Roma, Italy Department of Neurosciences, Mental Health, and Sensory Organs (NESMOS), School of Medicine and Psychology, Sapienza University, Rome, Italy.
authors.forename: Camilla
authors.initials: C
authors.lastname: Fini
authors.affiliation: Villa von Siebenthal, Genzano di Roma, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Motta
authors.affiliation: Department of Neurosciences, Mental Health, and Sensory Organs (NESMOS), School of Medicine and Psychology, Sapienza University, Rome, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Caloro
authors.affiliation: Department of Neurosciences, Mental Health, and Sensory Organs (NESMOS), School of Medicine and Psychology, Sapienza University, Rome, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Girardi
keywords: anxiety; asenapine; atypical antipsychotic drugs; bipolar disorder; substance use disorder