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Off-Label Use of Second-generation Antipsychotics in Bipolar Disorder

A Survey of Italian Psychiatrists

SALVI, VIRGINIO MD, PhD; CERVERI, GIANCARLO MD, PhD; AGUGLIA, ANDREA MD, PhD; CALÒ, SALVATORE MD, PhD; CORBO, MARIANGELA MD; MARTINOTTI, GIOVANNI MD, PhD; SERAFINI, GIANLUCA MD, PhD; SIGNORELLI, MARIA SALVINA MD, PhD; AGUGLIA, EUGENIO MD; AMORE, MARIO MD; BIGGIO, GIOVANNI MD; DI SCIASCIO, GUIDO MD; MENCACCI, CLAUDIO MD

Journal of Psychiatric Practice®: July 2019 - Volume 25 - Issue 4 - p 318–327
doi: 10.1097/PRA.0000000000000405
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Bipolar disorder (BD) is characterized by recurrent depressive and manic episodes. Lithium, valproate, lamotrigine, and some second-generation antipsychotics (SGAs) are the most typical pharmacological treatments for BD, the main goal being mood stabilization. However, despite these treatments, most patients continue to experience recurrent mood episodes and residual symptoms. Findings from several studies suggest that some SGAs may be beneficial beyond approved indications. The goal of the survey presented in this article was to examine Italian psychiatrists’ attitudes concerning the off-label use of SGAs in depressive and maintenance phases of BD. A questionnaire about the off-label prescription of SGAs was e-mailed to 300 psychiatrists from Northern, Central, and Southern Italy affiliated with the Italian Society of Psychopharmacology (SINPF) to investigate the frequency of and motivation for off-label use of SGAs and evaluate the psychiatrists’ attitude toward use of specific SGAs in BD; 202 questionnaires were completed. The respondents were equally distributed in terms of sex, and the mean age of respondents was 44.1 years. The majority of the sample reported use of SGAs for off-label indications either very often (16.7%), often (33.7%), or occasionally (34.7%). The main motivation for off-label use of the SGAs was the presence of published evidence (51.5%), followed by patients’ nonresponse to previous treatment (37.1%). With regard to the use of specific SGAs in BD, off-label aripiprazole was considered appropriate for depressive episodes by 46% of the psychiatrists, followed by olanzapine which was considered appropriate by 33.7%. For maintenance treatment of BD, off-label asenapine was considered appropriate by 45% of the psychiatrists, followed by long-acting aripiprazole and olanzapine pamoate, which were considered appropriate by 37.1% and 23.8%, respectively. In summary, ~50% of Italian psychiatrists frequently (very often or often) prescribe SGAs for off-label indications. Given the relatively limited number of indicated effective treatments for BD, the use of some SGAs off-label may be considered appropriate when dealing with patients whose BD is resistant to medications with labeled indications for BD.

SALVI, CERVERI, MENCACCI: Department of Neuroscience, ASST Fatebenefratelli Sacco, Milan, Italy

A. AGUGLIA: Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Psychiatry Unit, “IRCCS Policlinico San Martino” Hospital, Genoa, Italy and “Rita Levi Montalcini” Department of Neuroscience, University of Turin, Turin, Italy

CALÒ: Department of Mental Health, Local Health Agency, Lecce, Italy

CORBO: Department of Neuroscience Imaging and Clinical Science, “G. d’Annunzio” University of Chieti, Italy

MARTINOTTI: Department of Neuroscience Imaging and Clinical Science, “G. d’Annunzio” University of Chieti, Italy and Department of Pharmacy, Pharmacology and Clinical Science, University of Hertfordshire, Herts, UK

SERAFINI, AMORE: Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Psychiatry Unit, “IRCCS Policlinico San Martino” Hospital, Genoa, Italy

SIGNORELLI, E. AGUGLIA: Department of Experimental and Clinical Medicine, Psychiatric Clinic University Hospital “Gaspare Rodolico”, University of Catania, Catania, Italy

BIGGIO: Department of Life and Environmental Sciences, University of Cagliari, Cagliari, Italy

DI SCIASCIO: Department of Medical Basic Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Italy

The authors declare no conflicts of interest.

Please send correspondence to: Virginio Salvi, MD, PhD, ASST Fatebenefratelli Sacco, P.zza Principessa Clotilde 3, Milan 20121, Italy (e-mail: virginiosalvi@gmail.com).

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