PMID- 28255436
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240324
IS  - 2045-1253 (Print)
IS  - 2045-1261 (Electronic)
IS  - 2045-1253 (Linking)
VI  - 7
IP  - 2
DP  - 2017 Feb
TI  - Does the efficacy of asenapine in bipolar disorder increase in the presence of 
      comorbidity with a substance use disorder? A naturalistic study.
PG  - 67-77
LID - 10.1177/2045125316674698 [doi]
AB  - 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.
FAU - De Filippis, Sergio
AU  - De Filippis S
AD  - 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.
FAU - Cuomo, Ilaria
AU  - Cuomo I
AD  - Villa von Siebenthal Neuropsychiatric Clinic, Genzano di Roma, Via della 
      Madonnina 1, 00045 Genzano di Roma, Italy.
FAU - Kotzalidis, Georgios D
AU  - Kotzalidis GD
AD  - Department of Neurosciences, Mental Health, and Sensory Organs (NESMOS), School 
      of Medicine and Psychology, Sapienza University, Rome, Italy.
FAU - Pucci, Daniela
AU  - Pucci D
AD  - Department of Neurosciences, Mental Health, and Sensory Organs (NESMOS), School 
      of Medicine and Psychology, Sapienza University, Rome, Italy.
FAU - Zingaretti, Pietro
AU  - Zingaretti P
AD  - Villa von Siebenthal, Genzano di Roma, Italy.
FAU - Porrari, Raffaella
AU  - Porrari R
AD  - Villa von Siebenthal, Genzano di Roma, Italy.
FAU - Fini, Camilla
AU  - Fini C
AD  - 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.
FAU - Motta, Paola
AU  - Motta P
AD  - Villa von Siebenthal, Genzano di Roma, Italy.
FAU - Caloro, Matteo
AU  - Caloro M
AD  - Department of Neurosciences, Mental Health, and Sensory Organs (NESMOS), School 
      of Medicine and Psychology, Sapienza University, Rome, Italy.
FAU - Girardi, Paolo
AU  - Girardi P
AD  - Department of Neurosciences, Mental Health, and Sensory Organs (NESMOS), School 
      of Medicine and Psychology, Sapienza University, Rome, Italy.
LA  - eng
PT  - Journal Article
DEP - 20161028
PL  - England
TA  - Ther Adv Psychopharmacol
JT  - Therapeutic advances in psychopharmacology
JID - 101555693
PMC - PMC5315229
OTO - NOTNLM
OT  - anxiety
OT  - asenapine
OT  - atypical antipsychotic drugs
OT  - bipolar disorder
OT  - substance use disorder
COIS- Conflict of interest statement: The authors declare that there is no conflict of 
      interest.
EDAT- 2017/03/04 06:00
MHDA- 2017/03/04 06:01
PMCR- 2017/02/01
CRDT- 2017/03/04 06:00
PHST- 2017/03/04 06:00 [entrez]
PHST- 2017/03/04 06:00 [pubmed]
PHST- 2017/03/04 06:01 [medline]
PHST- 2017/02/01 00:00 [pmc-release]
AID - 10.1177_2045125316674698 [pii]
AID - 10.1177/2045125316674698 [doi]
PST - ppublish
SO  - Ther Adv Psychopharmacol. 2017 Feb;7(2):67-77. doi: 10.1177/2045125316674698. 
      Epub 2016 Oct 28.