Long-term efficacy and safety of aripiprazole in patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder: 26-week prospective study.
OBJECTIVE
To date there have been no reports of long-term efficacy of aripiprazole in Asian populations. The aim of the present study was therefore to investigate the long-term efficacy, safety and tolerability of aripiprazole in a large number of patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder in Korea.


METHODS
This study was a prospective, multicenter, single-group, 26-week open study of patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder. A total of 300 Korean patients participated in the study. The primary efficacy measure was the Positive and Negative Syndrome Scale (PANSS) total score, and secondary efficacy measures included the PANSS positive and negative subscales, Clinical Global Impression-Severity of Illness (CGI-S). Tolerability and safety were assessed by monitoring the frequency and severity of treatment-emergent adverse events, extrapyramidal symptoms (EPS), vital signs, weight, and laboratory tests.


RESULTS
Aripiprazole produced rapid and significant improvements on all efficacy measures. As evidenced by PANSS total score, PANSS positive subscales and the CGI-S scores, first-episode drug-naive patients demonstrated significantly greater efficacy relative to patients who had previously experienced one or more episodes of relapse. Aripiprazole was associated with significant decrease of serum prolactin level. The subjects showed mild weight gain.


CONCLUSIONS
Aripiprazole is an effective antipsychotic in the long-term treatment of both positive and negative symptoms. This study extends the findings of previous long-term studies, and has found that there is no significant difference with regard to ethnicity in response to aripiprazole.
Kwon
Jun Soo
JS
Department of Psychiatry, Seoul National University College of Medicine, Seoul, Korea. kwonjs@plaza.snu.ac.kr
Jang
Joon Hwan
JH
Kang
Do-Hyung
DH
Yoo
So Young
SY
Kim
Yong Ku
YK
Cho
Seong-Jin
SJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D001480:Basal Ganglia Diseases / Q000453:epidemiology / Q000523:psychology; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D005260:Female; D006801:Humans; D007723:Korea; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011388:Prolactin / Q000097:blood; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000188:drug therapy* / Q000523:psychology; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D013405:Suicide / Q000706:statistics & numerical data; D055815:Young Adult
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole; D011388:Prolactin