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Negative symptoms in schizophrenia: considerations for clinical trials |
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| Authors: | H. -J. Möller H. M. van Praag B. Aufdembrinke P. Bailey T. R. E. Barnes J. Beck H. Bentsen F. X. Eich L. Farrow W. W. Fleischhacker J. Gerlach K. Grafford B. Hentschel A. Hertkorn S. Heylen Y. Lecrubier J. P. Leonard P. McKenna W. Maier V. Pedersen A. Rappard W. Rein J. Ryan M. Sloth Nielsen R. -D. Stieglitz G. Wegener J. Wilson |
| Affiliation: | (1) Universitäts-Nervenklinik, D-53127 Bonn, Germany;(2) Academic Psychiatric Centre, NL-6202 AZ Maastricht, The Netherlands;(3) Schering AG, D-13353 Berlin, Germany;(4) Charing Cross and Westminster Medical School, London, United Kingdom;(5) Synthélabo Recherche, D-81925 München, Germany;(6) Gaustad Hospital, N-0320 Oslo, Norway;(7) Zeneca Pharmceuticals, Maccelsfield, Cheshire, United Kingdom;(8) Universitätsklinik, A-6020 Innsbruck, Austria;(9) St. Hans Hospital, DK-4000 Roskilde, Denmark;(10) Astra Arcus AB, S-15185 Södertälje, Sweden;(11) Hoechst AG, D-65929 Frankfurt am Main, Germany;(12) Janssen Research Foundation, B-2340 Beerse, Belgium;(13) U 302, Hôpital La Salpêtrière, F-75651 Paris Cedex 13, France;(14) Fulbourn Hospital, CB1 5EF Cambridge, United Kingdom;(15) Psychiatrische Universitätsklinik, D-55131 Mainz, Germany;(16) H. Lundbeck AS, DK-2500 Copenhagen Valby, Denmark;(17) Janssen GmbH, D-41470 Neuss, Germany;(18) Synthélabo Paris, F-92225 Bagneux Cedex, France;(19) Novo Nordisk A/S, DK-2760 Maløv, Denmark;(20) Psychiatrische Universitätsklinik, D-79104 Freiburg, Germany;(21) E. Merck, D-64293 Darmstadt, Germany;(22) Glaxo Group Research Ltd., Greenford, Middlesex, United Kingdom;(23) Boehringer Ingelheim Deutschland GmbH, Klinische Forschung Ingelheim, Binger Straße 173, D-55216 Ingelheim am Rhein, Germany |
| Abstract: | There is little agreement about the methodology of clinical trials of antipsychotic drugs in patients with negative symptoms. A literature review revealed wide variation in experimental design, rating scales and study duration. This reflects differing views as to the definition and response to treatment of negative symptoms. Some degree of standardization would improve comparability of studies and aid the development of new compounds. Patients included in such studies should have displayed negative symptoms for at least 6 months. Depressive symptoms, positive schizophrenic symptoms and extrapyramidal signs may all influence or be confused with negative symptoms and may respond to treatment; they should be at a low level at baseline and should be measured during the study period. Studies should last at least 8 weeks. Several scales are available for measuring negative symptoms and are reviewed; a global impression score should be used additionally. |
| Keywords: | Schizophrenia negative symptoms clinical trials psychiatric status rating scales neuroleptics |
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