A Critical Analysis and Discussion of the Appropriateness of the Schizophrenia Consensus Remission Criteria in Clinical Pharmaceutical Trials

Abstract

Background: The aim of this paper is to apply the proposed consensus remission criteria to an acutely ill inpatient sample at admission and evaluate their adaptability in this patient population and pharmaceutical trials.

Methods: The Remission in Schizophrenia Working Group's consensus criteria were applied to 272 acutely ill schizophrenia patients. Patients were examined using the PANSS, HAMD, UKU and SWN-K total scales at admission as well as the GAF, SOFAS and the Strauss-Carpenter Prognostic Scale. Sociodemographic and clinical baseline variables were assessed using a standardized documentation system.

Results: 33 patients (12%) fulfilled the symptom severity component of the proposed remission criteria already at baseline. Almost no significant differences were found when comparing patients with achieved and failed symptom severity component that would explain the hospitalization of the patients with achieved criteria despite their apparently mild psychopathological symptoms. The only explainable difference was that patients with an achieved symptom severity component had received significantly more antipsychotics and had suffered from significantly more life events before admission.

Conclusion: The present results raise the question whether the symptom severity threshold is adequate to identify patients in remission when applied in clinical trials.

References

• 1 Andreasen NC, Carpenter Jr WT, Kane JM. et al . Remission in schizophrenia: proposed criteria and rationale for consensus.  Am J Psychiatry. 2005;  162 441-449
• 2 Nasrallah HA, Lasser R. Improving patient outcomes in schizophrenia: achieving remission.  J Psychopharmacol. 2006;  20 (6 Suppl) 57-61
• 3 Kissling W, Heres S, Lloyd K. et al . Direct transition to long-acting risperidone – analysis of long-term efficacy.  J Psychopharmacol. 2005;  19 (5 Suppl) 15-21
• 4 Lasser RA, Bossie CA, Gharabawi GM. et al . Remission in schizophrenia: Results from a 1-year study of long-acting risperidone injection.  Schizophr Res. 2005;  77 215-227
• 5 Buckley PF, Harvey PD, Bowie CR. et al . The relationship between symptomatic remission and neuropsychological improvement in schizophrenia patients switched to treatment with ziprasidone.  Schizophr Res. 2007;  94 99-106
• 6 De HM, van WR, Wampers M. et al . Remission criteria for schizophrenia: evaluation in a large naturalistic cohort.  Schizophr Res. 2007;  92 68-73
• 7 Trivedi MH, Rush AJ, Wisniewski SR. et al . Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice.  Am J Psychiatry. 2006;  163 28-40
• 8 Wolwer W, Buchkremer G, Hafner H. et al . German research network on schizophrenia-bridging the gap between research and care.  Eur Arch Psychiatry Clin Neurosci. 2003;  253 321-329
• 9 Jager M, Riedel M, Messer T. et al . Psychopathological characteristics and treatment response of first episode compared with multiple episode schizophrenic disorders.  Eur Arch Psychiatry Clin Neurosci. 2007;  257 47-53
• 10 American Psychiatric Association .Diagnostic and Statistical Manual of Mental Disorders. Washington DC, American Psychiatric Association; 1994
• 11 Cording C. Conceptual aspects in development and implementation of basic psychiatric documentation.  Psychiatr Prax. 1998;  25 175-178
• 12 Kay SR, Opler LA, Lindenmayer JP. Reliability and validity of the positive and negative syndrome scale for schizophrenics.  Psychiatry Res. 1988;  23 99-110
• 13 Hamilton M. Development of a rating scale for primary depressive illness.  Br J Soc Clin Psychol. 1967;  6 278-296
• 14 Guy W. Clinical Global Impressions. ECDEU Assessment Manual for Psychopharmacology 1976.  National Institute of Mental Health, Rockville, MD revised
• 15 Naber D, Moritz S, Lambert M. et al . Improvement of schizophrenic patients’ subjective well-being under atypical antipsychotic drugs.  Schizophr Res. 2001;  50 79-88
• 16 American Psychiatric Association .Diagnostic and Statistical Manual of Mental Disorders. Washington DC, American Psychiatric Association; 1987
• 17 Kokes RF, Strauss JS, Klorman R. Premorbid adjustment in schizophrenia. Part II. Measuring premorbid adjustment: the instruments and their development.  Schizophr Bull. 1977;  3 186-213
• 18 Leucht S, Beitinger R, Kissling W. On the concept of remission in schizophrenia.  Psychopharmacology (Berl). 2007;  194 453-461
• 19 Leucht S, Davis JM, Engel RR. et al . Definitions of response and remission in schizophrenia: recommendations for their use and their presentation.  Acta Psychiatr Scand Suppl. 2009;  438 7-14
• 20 Lister TA, Armitage JO. Non-Hodgkin's lymphoma, in Clinical Oncology. New York, Churchill Livingstone; 2000
• 21 Prevoo ML, van Gestel AM, van THM. et al . Remission in a prospective study of patients with rheumatoid arthritis. American Rheumatism Association preliminary remission criteria in relation to the disease activity score.  Br J Rheumatol. 1996;  35 1101-1105
• 22 Clark W, Jobanputra P, Barton P. et al . The clinical and cost-effectiveness of anakinra for the treatment of rheumatoid arthritis in adults: a systematic review and economic analysis.  Health Technol Assess. 2004;  8 iii-x 1
• 23 Moller HJ. Outcomes in major depressive disorder: the evolving concept of remission and its implications for treatment.  World J Biol Psychiatry. 2008;  9 102-114
• 24 Moller HJ. Standardised rating scales in psychiatry: Methodological basis, their possibilities and limitations and descriptions of important rating scales.  World J Biol Psychiatry. 2009;  10 6-26
• 25 Moller HJ. The forthcoming revision of the diagnostic and classificatory system: perspectives based on the European psychiatric tradition.  Eur Arch Psychiatry Clin Neurosci. 2008;  258 (S 05) 7-17

Correspondence