ABSTRACT
OBJECTIVE: The purpose of the present study was to investigate the efficacy, safety, and tolerability of aripiprazole in patients with schizophrenia, schizophreniform disorder, and schizoaffective disorder during acute treatment phase. METHODS: Prospective, multicenter, single group, and 8-week study was conducted in patients with schizophrenia, schizophreniform disorder, and schizoaffective disorder. A total of 300 patients were enrolled in the present study. The primary efficacy measure was the Positive and Negative Syndrome Scale (PANSS) total score, and secondary efficacy measures were the PANSS positive and negative subscales scores, and Clinical Global Impression-Severity of Illness (CGI-S) score. Treatment-emergent adverse events, extrapyramidal symptoms (EPS), weight, vital signs, and laboratory tests were assessed as measures of tolerability and safety. RESULTS: Significant improvements in all efficacy measures were achieved by aripiprazole as early as 1-week and sustained through 8-week period. First-episode patients showed greater improvements in PANSS total, positive subscale score, and CGI-S score, compared with recurrent patients. Slightly increased akathisia (+0.32 from baseline score of Barnes Akathisia Rating Scale, p=0.033) and weight gain (1.15+/-3.44 kg, p<0.001) were observed by aripiprazole during 8-week acute treatment phase. CONCLUSION: The present study demonstrated that aripiprazole was effective in acute treatment of positive and negative symptoms of schizophrenia, schizophreniform disorder, and schizoaffective disorder. In general, aripiprazole showed favorable safety and tolerability profiles, although clinicians needed to pay attention to the possibility of akathisia and weight gain by aripiprazole in first-episode patients during acute treatment phase.
Subject(s)
Humans , Piperazines , Prospective Studies , Psychomotor Agitation , Psychotic Disorders , Quinolones , Schizophrenia , Vital Signs , Weight Gain , AripiprazoleABSTRACT
OBJECTIVE: The purpose of the present study was to investigate the efficacy, safety, and tolerability of aripiprazole in patients with schizophrenia, schizophreniform disorder, and schizoaffective disorder during acute treatment phase. METHODS: Prospective, multicenter, single group, and 8-week study was conducted in patients with schizophrenia, schizophreniform disorder, and schizoaffective disorder. A total of 300 patients were enrolled in the present study. The primary efficacy measure was the Positive and Negative Syndrome Scale (PANSS) total score, and secondary efficacy measures were the PANSS positive and negative subscales scores, and Clinical Global Impression-Severity of Illness (CGI-S) score. Treatment-emergent adverse events, extrapyramidal symptoms (EPS), weight, vital signs, and laboratory tests were assessed as measures of tolerability and safety. RESULTS: Significant improvements in all efficacy measures were achieved by aripiprazole as early as 1-week and sustained through 8-week period. First-episode patients showed greater improvements in PANSS total, positive subscale score, and CGI-S score, compared with recurrent patients. Slightly increased akathisia (+0.32 from baseline score of Barnes Akathisia Rating Scale, p=0.033) and weight gain (1.15+/-3.44 kg, p<0.001) were observed by aripiprazole during 8-week acute treatment phase. CONCLUSION: The present study demonstrated that aripiprazole was effective in acute treatment of positive and negative symptoms of schizophrenia, schizophreniform disorder, and schizoaffective disorder. In general, aripiprazole showed favorable safety and tolerability profiles, although clinicians needed to pay attention to the possibility of akathisia and weight gain by aripiprazole in first-episode patients during acute treatment phase.