The primary objective of this study was to evaluate the efficacy, safety and tolerability of remoxipride (controlled release) versus haloperidol in patients with negative symptoms. The study comprised a multicentre, randomised, double-blind, parallel-group clinical trial. Two hundred and five patients were randomised to either remoxipride or haloperidol. Patients eligible for this study were aged 18-65 years, met the DSM-III-R diagnosis for chronic schizophrenia and the Positive and Negative Symptoms Scale (PANSS) criteria for predominant negative symptoms. There was a statistically significant reduction in the PANSS scores of at least 20% from baseline to last rating for 39 remoxipride (49.4%) and 45 haloperidol (47.6%) treated patients. There were no statistical differences found between the two treatment groups with respect to improvement of negative symptoms and adverse events. The PANSS data suggest that both remoxipride and haloperidol improve the cluster of negative symptoms concerned with social functioning. In addition, the design of the study provides a methodology that is appropriate to the study of primary negative symptoms in schizophrenia.

The object of the study was to investigate the effect of EMLA cream when used as an anaesthetic for the debridement of ulcers and wounds. The cream was applied to a fresh, standardized wound caused by a dermatome, to an ulcer which was to be revised and for simultaneous split-skin grafting to both donor site and recipient area to be debrided. The effect on wound healing, the plasma concentrations of lidocaine and prilocaine and the analgesic effect following the application of EMLA to the ulcer and to both ulcer and donor site were studied. The study showed that EMLA cream when topically applied has a sufficient analgesic effect for revision of an open ulcer and can be used concomitantly for both revision of the ulcer and cutting of the split-skin graft. The application of EMLA cream to the fresh wound, or to the recipient area prior to cleaning, did not cause any clinical signs of a delayed healing at the applied areas compared to the control sites.

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.