EPA guidance on assessment of negative symptoms in schizophrenia

S Galderisi, A Mucci, S Dollfus, M Nordentoft, P Falkai, S Kaiser, G M Giordano, A Vandevelde, M Ø Nielsen, L B Glenthøj, M Sabé, P Pezzella, I Bitter, W Gaebel, S Galderisi, A Mucci, S Dollfus, M Nordentoft, P Falkai, S Kaiser, G M Giordano, A Vandevelde, M Ø Nielsen, L B Glenthøj, M Sabé, P Pezzella, I Bitter, W Gaebel

Abstract

Background: During the last decades, a renewed interest for negative symptoms (NS) was brought about by the increased awareness that they interfere severely with real-life functioning, particularly when they are primary and persistent.

Methods: In this guidance paper, we provide a systematic review of the evidence and elaborate several recommendations for the conceptualization and assessment of NS in clinical trials and practice.

Results: Expert consensus and systematic reviews have provided guidance for the optimal assessment of primary and persistent negative symptoms; second-generation rating scales, which provide a better assessment of the experiential domains, are available; however, NS are still poorly assessed both in research and clinical settings.This European Psychiatric Association (EPA) guidance recommends the use of persistent negative symptoms (PNS) construct in the context of clinical trials and highlights the need for further efforts to make the definition of PNS consistent across studies in order to exclude as much as possible secondary negative symptoms. We also encourage clinicians to use second-generation scales, at least to complement first-generation ones.The EPA guidance further recommends the evidence-based exclusion of several items included in first-generation scales from any NS summary or factor score to improve NS measurement in research and clinical settings. Self-rated instruments are suggested to further complement observer-rated scales in NS assessment.Several recommendations are provided for the identification of secondary negative symptoms in clinical settings.

Conclusions: The dissemination of this guidance paper may promote the development of national guidelines on negative symptom assessment and ultimately improve the care of people with schizophrenia.

Keywords: Assessment instruments; conceptualization; persistent negative symptoms; primary negative symptoms; secondary negative symptoms.

Conflict of interest statement

S. Galderisi has been a consultant and/or advisor to or has received honoraria or grants from:

Millennium Pharmaceuticals, Innova Pharma-Recordati Group, Janssen Pharmaceutica NV, Sunovion Pharmarmaceuticals, Janssen-Cilag Polska Sp. zo. o., Gedeon Richter-Recordati, Pierre Fabre, Otsuka, Angelini.

A. Mucci received honoraria, advisory board, or consulting fees from the following companies:

Amgen Dompé, Angelini-Acraf, Astra Zeneca, Bristol-Myers Squibb, Gedeon Richter Bulgaria, Innova-Pharma, Janssen Pharmaceuticals, Lundbeck, Otsuka, Pfizer, and Pierre Fabre.

S. Dollfus received honoraria as expert/consultant by Fabre, Gedeon, Roche, and Takeda; invited Conferences: Lundbeck, Otsuka, Janssen, and has contracts with Prophase MedAvances and NeuroCogTrials.

S. Kaiser has received speaker honoraria from Recordati and Lundbeck as well as royalties for cognitive training software from Schuhfried.

I. Bitter has received in the past 5 years honoraria or consultation fees from Angelini, Eli Lilly, Gedeon Richter, Janssen/Janssen Cilag, and Sun Pharma.

All other authors declare no conflict of interest.

Figures

Figure 1.
Figure 1.
PRISMA flowchart of studies retrieved in the systematic literature search. *11905 duplicates; 1826 studies other than meta-analysis, randomized controlled trial, review, cohort study, open study, descriptive study, expert opinion; 843 studies published in journal not indexed in Embase or Medline; 2895 studies on pathophysiological mechanisms of negative symptoms; 5813 articles not related to any topic; 1527 articles related to the treatment of negative symptoms; 158 studies conducted in animals. **The deviation from the original search regarded the Sections: “Assessment of negative symptoms in First Episode Psychosis patients” (N = 8; the other 23 had been already included in the 256 documents of the original search) and “Assessment of negative symptoms in clinical high risk individuals” (N = 24; the other 17 had been already included in the 256 documents of the original search).
Figure 2.
Figure 2.
Clinical suspicion of negative symptoms—decision tree NS: negative symptoms; PANSS: Positive and Negative Syndrome Scale; SANS: Scale for the Assessment of Negative Symptoms; BNSS: Brief Negative Symptom Scale; CAINS: Clinical Assessment Interview for Negative Symptoms; SNS: Self-evaluation of Negative Symptoms; MAP-SR: Motivation and Pleasure Scale-Self-Report. The square brackets in the figure report the corresponding number and grade of the recommendations present in the text. PANSS items: N1 = Blunted affect, N2 = Emotional withdrawal, N3 = Poor rapport, N4 = Passive/apathetic social withdrawal, N6 = Lack of spontaneity and flow of conversation; *SANS Affective Flattening or Blunting subscale items: 1 = Unchanging facial expression, 2 = Decreased spontaneous movements, 3 = Paucity of expressive gestures, 4 = Poor eye contact, 5 = Affective nonresponsivity, 7 = Lack of vocal inflections; SANS Alogia subscale items: 9 = Poverty of speech, 11 = Blocking, 12 = Increased Latency of Response; #SANS Avolition-apathy subscale items: 14 = Grooming and Hygiene, 15 = Impersistence at work or school, 16 = Physical anergia; §SANS Anhedonia-Asociality subscale items: 18 = Recreational Interests and Activities, 19 = Sexual interest and activity, 20 = Ability to feel intimacy and closeness, 21 = Relationships with friends and peers.

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