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)

• Published in: Schizophrenia research 2006-05, Vol.84 (1), p.77-89
• Main Authors: Tandon, Rajiv, Marcus, Ronald N., Stock, Elyse G., Riera, Linda C., Kostic, Dusan, Pans, Miranda, McQuade, Robert D., Nyilas, Margaretta, Iwamoto, Taro, Crandall, David T.
• Format: Article
• Language: English
• Subjects: Adult; Adult and adolescent clinical studies; Ambulatory Care; Antipsychotic Agents - therapeutic use; Aripiprazole; Atypical antipsychotic; Biological and medical sciences; Clinical trial; Drug Administration Schedule; Female; Humans; Male; Medical sciences; Neuropharmacology; Outpatient; Pharmacology. Drug treatments; Piperazines - therapeutic use; Primary Health Care - methods; Prospective Studies; Psychiatry - methods; Psycholeptics: tranquillizer, neuroleptic; Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Psychopharmacology; Psychoses; Psychotic Disorders - diagnosis; Psychotic Disorders - drug therapy; Quinolones - therapeutic use; RCT; Schizoaffective disorder; Schizophrenia; Schizophrenia - diagnosis; Schizophrenia - drug therapy; Switch study; Treatment Outcome
• ISSN: 0920-9964; 1573-2509
• DOI: 10.1016/j.schres.2005.12.857

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. In this 8-week, multicenter, open-label study, 1599 outpatients with schizophrenia or schizoaffective disorder were randomly assigned to receive either aripiprazole ( n = 1295) 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. 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%). 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.