PMID- 10836281 OWN - NLM STAT- MEDLINE DCOM- 20000925 LR - 20191025 IS - 0268-1315 (Print) IS - 0268-1315 (Linking) VI - 15 IP - 1 DP - 2000 Jan TI - Long-term safety and efficacy of amisulpride in subchronic or chronic schizophrenia. Amisulpride Study Group. PG - 13-22 AB - Amisulpride is an atypical antipsychotic with selective affinity for dopamine D2/3 receptors. In this long-term, open, randomised, multicentre trial, patients with chronic or subchronic schizophrenia received amisulpride (n =370) or haloperidol (n = 118) for 12 months. Dosage regimens were flexible (amisulpride 200-800 mg/day, haloperidol 5-20 mg/day). Improvement in mean Brief Psychiatric Rating Scale total score was significantly greater for amisulpride than haloperidol (17.0 versus 12.8, P = 0.01). Positive symptoms (Positive and Negative Syndrome Scale [PANSS] positive) improved in a similar way in each group but amisulpride caused a significantly better improvement in negative symptoms (PANSS negative) (7.1 versus 3.7, P < 0.0001). Improvements in Global Assessment of Functioning (GAF) and Quality of Life Scale (QLS) scores were also significantly greater in the amisulpride group (GAF -20.1 versus -13.6, P = 0.001; QLS -0.64 versus -0.30, P = 0.02). Adverse events were mainly psychiatric in nature, and occurred with similar frequency in each group (amisulpride 254/370, 69%; haloperidol 82/118, 70%). Extrapyramidal symptoms were more frequent for haloperidol (48/118, 41% versus 96/370, 26% for amisulpride), leading to a greater requirement for antiparkinsonian medication (haloperidol 66/118, 56% versus amisulpride 118/370, 32%). Haloperidol significantly aggravated parkinsonism, akathisia and involuntary movement compared to amisulpride. The overall incidence of endocrine events was comparable between groups (4% for amisulpride, 3% for haloperidol). Maintenance of efficacy was comparable in both treatment groups; 59% of amisulpride patients and 55% of haloperidol patients improved after 1 month of therapy remained improved throughout the study period. Amisulpride is effective following flexible long-term administration and significantly improves social functioning and quality of life. FAU - Colonna, L AU - Colonna L AD - Unite de Psychiatrie,CHU Charles Nicolle, Rouen, France, FAU - Saleem, P AU - Saleem P FAU - Dondey-Nouvel, L AU - Dondey-Nouvel L FAU - Rein, W AU - Rein W LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PL - England TA - Int Clin Psychopharmacol JT - International clinical psychopharmacology JID - 8609061 RN - 0 (Antipsychotic Agents) RN - 7MNE9M8287 (Sulpiride) RN - 8110R61I4U (Amisulpride) RN - J6292F8L3D (Haloperidol) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Amisulpride MH - Antipsychotic Agents/*adverse effects/*therapeutic use MH - Chronic Disease MH - Dyskinesia, Drug-Induced/epidemiology MH - Female MH - Haloperidol/adverse effects/therapeutic use MH - Humans MH - Male MH - Middle Aged MH - Psychiatric Status Rating Scales MH - Schizophrenia/*drug therapy MH - Sulpiride/adverse effects/*analogs & derivatives/therapeutic use EDAT- 2000/06/03 09:00 MHDA- 2000/09/30 11:01 CRDT- 2000/06/03 09:00 PHST- 2000/06/03 09:00 [pubmed] PHST- 2000/09/30 11:01 [medline] PHST- 2000/06/03 09:00 [entrez] AID - 10.1097/00004850-200015010-00002 [doi] PST - ppublish SO - Int Clin Psychopharmacol. 2000 Jan;15(1):13-22. doi: 10.1097/00004850-200015010-00002.