a multicentric retrospective observational study of the ......long-acting injection antipsychotics...

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L. Orsolini 1-4 , D. De Berardis 2,5,6 , A. Carano 7 , C. Tomasetti 2,8 , R. Vecchiotti 1-3 , F. Iasevoli 2,8 , G. Martinotti 6 , A. Valchera 1,2 ¹ Villa S. Giuseppe Hospital, Hermanas Hospitalarias, Ascoli Piceno, Italy; 2 Polyedra Research Group, Teramo, Italy; 3 Department of Psychiatry and Neuropsychology, Maastricht University, Maastricht, Netherlands 4 School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, UK; 5 NHS, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital “G. Mazzini”, ASL 4 Teramo, Italy 6 Department of Neuroscience, Imaging and Clinical Science, Chair of Psychiatry, University “G. D’Annunzio”, Chieti, Italy; 7 NHS, Department of Mental Health ASL Ascoli Piceno, Psychiatric Service of Diagnosis and Treatment, Hospital “Madonna del Soccorso”, San Benedetto del Tronto, Italy; 8 Laboratory of Molecular Psychiatry and Psychopharmacotherapeutics, Section of Psychiatry, Department of Neuroscience, University School of Medicine “Federico II”, Naples, Italy A multicentric retrospective observational study of the effectiveness of paliperidone palmitate long-acting injection (PP-LAI) on non-core symptoms of schizophrenia INTRODUCTION Schizophrenia is a severe mental illness that may require the administration of second-generation long-acting injection antipsychotics (SGA LAIs) to reduce the likelihood of relapse/hospitalization and allow the maintenance of an adequate treatment. Although SGA LAIs appear to be effective in the treatment and the improvement of core symptoms (e.g., delusions; disturbances in perception, abnormalities in communication/behavior/motor activity, and deficits in emotional expressivity/hedonic capacity/drive) of the illness, no definitive and clear conclusions could be drawn up on their short-/long-term effects in the improvement of non-core symptoms. AIMS: The present study aims at conducting a multicentric retrospective observational study of the effectiveness of paliperidone palmitate long-acting injection (PP-LAI) in the following non-core dimensions of schizophrenia: Copyright © 2016 Orsolini L. et al. Villa San Giuseppe Hospital, Ascoli Piceno; Polyedra Research, Teramo, Italy; and School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, UK. Email: [email protected] Social and working functioning OC- symptoms Affective Dimension Social Functioning Scale [SFS] Clinical Global Impression [CGI] Short-Form 36 Healthy- Survey Questionnai re [SF-36] Aggressiveness and impulsiveness Y-BOCS Calgary Depression Scale [CDS] Mania Rating Scale [MRS] Hamilton Anxiety Rating Scale [HARS] Hamilton Depression Rating Scale [HARS] Aggression Questionnaire [AQ] Barratt Impulsiveness Scale[BIS-11] Compliance and Treatment Adherence Drug Attitude Inventory [DAI] METHODS: All LAI-naïve patients commenced and currently on PP-LAI for at least 3 months, will be progressively recruited in a 12-month period. a) Psychiatric Service of Diagnosis and Treatment, Hospital “G. Mazzini”, Teramo, Italy; b) Psychiatric Service of Diagnosis and Treatment, Hospital “Madonna del Soccorso”, San Benedetto del Tronto, Italy; c) Psychiatric Service of Diagnosis and Treatment, “Maria SS dello Splendore”, Giulianova, Italy; d) Villa San Giuseppe Hospital, Ascoli Piceno, Italy. Psychiatric history Current Psychiatric status BPRS PANSS

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Page 1: A multicentric retrospective observational study of the ......long-acting injection antipsychotics (SGA LAIs) to reduce the likelihood of relapse/hospitalization and allow the maintenance

L. Orsolini1-4, D. De Berardis2,5,6, A. Carano7, C. Tomasetti2,8, R. Vecchiotti1-3, F. Iasevoli2,8,

G. Martinotti6, A. Valchera1,2 ¹ Villa S. Giuseppe Hospital, Hermanas Hospitalarias, Ascoli Piceno, Italy; 2 Polyedra Research Group, Teramo, Italy; 3 Department of Psychiatry and Neuropsychology, Maastricht University, Maastricht, Netherlands 4 School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, UK; 5 NHS, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital “G. Mazzini”, ASL 4 Teramo, Italy 6 Department of Neuroscience, Imaging and Clinical Science, Chair of Psychiatry, University “G. D’Annunzio”, Chieti, Italy; 7 NHS, Department of Mental Health ASL Ascoli Piceno, Psychiatric Service of Diagnosis and

Treatment, Hospital “Madonna del Soccorso”, San Benedetto del Tronto, Italy; 8 Laboratory of Molecular Psychiatry and Psychopharmacotherapeutics, Section of Psychiatry, Department of Neuroscience, University

School of Medicine “Federico II”, Naples, Italy

A multicentric retrospective observational study of the effectiveness of paliperidone palmitate long-acting injection (PP-LAI) on non-core symptoms of schizophrenia

INTRODUCTION Schizophrenia is a severe mental illness that may require the administration of second-generation

long-acting injection antipsychotics (SGA LAIs) to reduce the likelihood of relapse/hospitalization and

allow the maintenance of an adequate treatment. Although SGA LAIs appear to be effective in the

treatment and the improvement of core symptoms (e.g., delusions; disturbances in perception,

abnormalities in communication/behavior/motor activity, and deficits in emotional

expressivity/hedonic capacity/drive) of the illness, no definitive and clear conclusions could be drawn

up on their short-/long-term effects in the improvement of non-core symptoms.

AIMS: The present study aims at conducting a multicentric

retrospective observational study of the effectiveness

of paliperidone palmitate long-acting injection (PP-LAI)

in the following non-core dimensions of schizophrenia:

Copyright © 2016 Orsolini L. et al. Villa San Giuseppe Hospital, Ascoli Piceno; Polyedra Research, Teramo, Italy; and School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, UK. Email:

[email protected]

Social and

working

functioning

OC-

symptoms

Affective

Dimension

Social

Functioning

Scale [SFS]

Clinical

Global

Impression

[CGI]

Short-Form

36 Healthy-

Survey

Questionnai

re [SF-36]

Aggressiveness

and impulsiveness

Y-BOCS

Calgary

Depression

Scale [CDS]

Mania

Rating

Scale [MRS]

Hamilton

Anxiety

Rating

Scale

[HARS]

Hamilton

Depression

Rating

Scale

[HARS]

Aggression

Questionnaire

[AQ]

Barratt

Impulsiveness

Scale[BIS-11]

Compliance and

Treatment

Adherence

Drug Attitude

Inventory

[DAI]

METHODS: All LAI-naïve patients commenced

and currently on PP-LAI for at least 3 months, will

be progressively recruited in a 12-month period.

a) Psychiatric Service of Diagnosis and

Treatment, Hospital “G. Mazzini”, Teramo,

Italy;

b) Psychiatric Service of Diagnosis and

Treatment, Hospital “Madonna del Soccorso”,

San Benedetto del Tronto, Italy;

c) Psychiatric Service of Diagnosis and

Treatment, “Maria SS dello Splendore”,

Giulianova, Italy;

d) Villa San Giuseppe Hospital, Ascoli Piceno,

Italy.

Psychiatric history

Current Psychiatric

status BPRS

PANSS