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).
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.
Florida Department of Children and Families, 1317 Winewood Boulevard, Tallahassee, FL 32399, USA. rajiv_tandon@dcf.state.fl.us
Rajiv
R
Tandon
Ronald N
RN
Marcus
Elyse G
EG
Stock
Linda C
LC
Riera
Dusan
D
Kostic
Miranda
M
Pans
Robert D
RD
McQuade
Margaretta
M
Nyilas
Taro
T
Iwamoto
David T
DT
Crandall
D000328:Adult; D000553:Ambulatory Care; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D010879:Piperazines / Q000627:therapeutic use*; D011320:Primary Health Care / Q000379:methods*; D011446:Prospective Studies; D011570:Psychiatry / Q000379:methods*; D011618:Psychotic Disorders / Q000175:diagnosis / Q000188:drug therapy*; D015363:Quinolones / Q000627:therapeutic use*; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole