PMID- 16483745 OWN - NLM STAT- MEDLINE DCOM- 20060908 LR - 20220409 IS - 0920-9964 (Print) IS - 0920-9964 (Linking) VI - 84 IP - 1 DP - 2006 May TI - A prospective, multicenter, randomized, parallel-group, open-label study of aripiprazole in the management of patients with schizophrenia or schizoaffective disorder in general psychiatric practice: Broad Effectiveness Trial With Aripiprazole (BETA). PG - 77-89 AB - OBJECTIVE: BETA was designed to evaluate the overall effectiveness of aripiprazole in patients with schizophrenia or schizoaffective disorder treated in a general psychiatry outpatient practice setting. METHODS: In this 8-week, multicenter, open-label study, 1,599 outpatients with schizophrenia or schizoaffective disorder were randomly assigned to receive either aripiprazole (n=1,295) or another antipsychotic medication (safety control [SC] group; n=304). Aripiprazole was initiated at 15 mg/d with the option to adjust between 10-30 mg/d. The SC medication was specifically selected for each patient by the clinician and dosed according to prescribing guidelines for that medication. The primary effectiveness measure was the Clinical Global Impression-Improvement (CGI-I) score of the aripiprazole group at study end point. Secondary measures included response rates and preference of medicine (POM) ratings by patients and caregivers. RESULTS: Sixty-five percent of aripiprazole patients completed the study. The mean aripiprazole dose at end point was 19.9 mg/d, with approximately 39% of patients starting and remaining at 15 mg/d. At end point, the mean CGI-I score of 2.77 demonstrated that aripiprazole was minimally to moderately effective; the mean CGI-I score for the SC group was 3.59 indicating minimally effective to no change. Fifty-three percent of aripiprazole patients responded to treatment (CGI-I score of 1 or 2; last-observation-carried-forward [LOCF]), and approximately 71% of patients and caregivers rated aripiprazole as better than the prestudy medication on the POM (LOCF). Incidence and severity of adverse events (AEs) were similar to those reported in double-blind, randomized, placebo-controlled aripiprazole clinical trials. The most frequent AE in the aripiprazole group was insomnia (24%). CONCLUSIONS: Aripiprazole was effective for the treatment of schizophrenia and schizoaffective disorder in a general psychiatry outpatient practice setting. Overall, aripiprazole was found to be effective by the treating clinician and well accepted by patients and caregivers over the 8-week treatment course. FAU - Tandon, Rajiv AU - Tandon R AD - Florida Department of Children and Families, 1317 Winewood Boulevard, Tallahassee, FL 32399, USA. rajiv_tandon@dcf.state.fl.us FAU - Marcus, Ronald N AU - Marcus RN FAU - Stock, Elyse G AU - Stock EG FAU - Riera, Linda C AU - Riera LC FAU - Kostic, Dusan AU - Kostic D FAU - Pans, Miranda AU - Pans M FAU - McQuade, Robert D AU - McQuade RD FAU - Nyilas, Margaretta AU - Nyilas M FAU - Iwamoto, Taro AU - Iwamoto T FAU - Crandall, David T AU - Crandall DT LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20060214 PL - Netherlands TA - Schizophr Res JT - Schizophrenia research JID - 8804207 RN - 0 (Antipsychotic Agents) RN - 0 (Piperazines) RN - 0 (Quinolones) RN - 82VFR53I78 (Aripiprazole) SB - IM MH - Adult MH - Ambulatory Care MH - Antipsychotic Agents/*therapeutic use MH - Aripiprazole MH - Drug Administration Schedule MH - Female MH - Humans MH - Male MH - Piperazines/*therapeutic use MH - Primary Health Care/*methods MH - Prospective Studies MH - Psychiatry/*methods MH - Psychotic Disorders/diagnosis/*drug therapy MH - Quinolones/*therapeutic use MH - Schizophrenia/diagnosis/*drug therapy MH - Treatment Outcome EDAT- 2006/02/18 09:00 MHDA- 2006/09/09 09:00 CRDT- 2006/02/18 09:00 PHST- 2005/07/11 00:00 [received] PHST- 2005/12/27 00:00 [revised] PHST- 2005/12/29 00:00 [accepted] PHST- 2006/02/18 09:00 [pubmed] PHST- 2006/09/09 09:00 [medline] PHST- 2006/02/18 09:00 [entrez] AID - S0920-9964(06)00014-4 [pii] AID - 10.1016/j.schres.2005.12.857 [doi] PST - ppublish SO - Schizophr Res. 2006 May;84(1):77-89. doi: 10.1016/j.schres.2005.12.857. Epub 2006 Feb 14.