Abstract
Japan approved clozapine for treatment-resistant schizophrenia in June 2009. The aim of this study was to evaluate clozapine's efficacy and tolerability in Japanese patients. A twelve-week, single-arm clinical trial of clozapine in treatment-resistant schizophrenia inpatients, was conducted under real-world conditions using raters masked for type of antipsychotic. Thirty-eight patients were recruited, with 33 (86.8%) completing the trial. At week 12, clozapine was associated with significant improvement in the Positive and Negative Syndrome Scale (PANSS) total (p<0.0001), PANSS positive (p<0.0001), negative (p=0.0055) and general subscale scores (p<0.0001). Significant improvements occurred in all PANSS scores by week 4, the first post-baseline psychopathology rating. Altogether, 50.0% of patients showed ≥20% reduction in PANSS total score, 20.6% had ≥30% reduction and 14.7% had >40% reduction. Eighteen patients (47.4%) were discharged before week 12. However, all patients experienced ≥1 adverse event. Two of 38 patients (5.2%) dropped out due to moderate leucopenia and one of them developed agranulocytosis after stopping clozapine. However, both patients recovered. Eight adverse events (hypersalivation, fatigue, sedation, constipation, insomnia, nausea/vomiting, chest pain and leucopenia) were observed in 34-79% of patients. These findings suggest that clozapine is beneficial in Japanese treatment-resistant schizophrenia patients. However, attention should be paid to patients' adverse events.
| Original language | English |
|---|---|
| Pages (from-to) | 200-207 |
| Number of pages | 8 |
| Journal | Asian Journal of Psychiatry |
| Volume | 6 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 01-06-2013 |
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All Science Journal Classification (ASJC) codes
- Psychology(all)
- Psychiatry and Mental health
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Efficacy and tolerability of clozapine in Japanese patients with treatment-resistant schizophrenia : Results from a 12-week, flexible dose study using raters masked to antipsychotic choice. / Kishi, Taro; Fujita, Kiyoshi; Furukawa, Osamu; Suzuki, Tatsuyo; Moriwaki, Masatsugu; Nitta, Mari; Hattori, Miho; Tsunoka, Tomoko; Chekuri, Raja; Kane, John M.; Correll, Christoph U.; Iwata, Nakao.
In: Asian Journal of Psychiatry, Vol. 6, No. 3, 01.06.2013, p. 200-207.Research output: Contribution to journal › Article
TY - JOUR
T1 - Efficacy and tolerability of clozapine in Japanese patients with treatment-resistant schizophrenia
T2 - Results from a 12-week, flexible dose study using raters masked to antipsychotic choice
AU - Kishi, Taro
AU - Fujita, Kiyoshi
AU - Furukawa, Osamu
AU - Suzuki, Tatsuyo
AU - Moriwaki, Masatsugu
AU - Nitta, Mari
AU - Hattori, Miho
AU - Tsunoka, Tomoko
AU - Chekuri, Raja
AU - Kane, John M.
AU - Correll, Christoph U.
AU - Iwata, Nakao
PY - 2013/6/1
Y1 - 2013/6/1
N2 - Japan approved clozapine for treatment-resistant schizophrenia in June 2009. The aim of this study was to evaluate clozapine's efficacy and tolerability in Japanese patients. A twelve-week, single-arm clinical trial of clozapine in treatment-resistant schizophrenia inpatients, was conducted under real-world conditions using raters masked for type of antipsychotic. Thirty-eight patients were recruited, with 33 (86.8%) completing the trial. At week 12, clozapine was associated with significant improvement in the Positive and Negative Syndrome Scale (PANSS) total (p<0.0001), PANSS positive (p<0.0001), negative (p=0.0055) and general subscale scores (p<0.0001). Significant improvements occurred in all PANSS scores by week 4, the first post-baseline psychopathology rating. Altogether, 50.0% of patients showed ≥20% reduction in PANSS total score, 20.6% had ≥30% reduction and 14.7% had >40% reduction. Eighteen patients (47.4%) were discharged before week 12. However, all patients experienced ≥1 adverse event. Two of 38 patients (5.2%) dropped out due to moderate leucopenia and one of them developed agranulocytosis after stopping clozapine. However, both patients recovered. Eight adverse events (hypersalivation, fatigue, sedation, constipation, insomnia, nausea/vomiting, chest pain and leucopenia) were observed in 34-79% of patients. These findings suggest that clozapine is beneficial in Japanese treatment-resistant schizophrenia patients. However, attention should be paid to patients' adverse events.
AB - Japan approved clozapine for treatment-resistant schizophrenia in June 2009. The aim of this study was to evaluate clozapine's efficacy and tolerability in Japanese patients. A twelve-week, single-arm clinical trial of clozapine in treatment-resistant schizophrenia inpatients, was conducted under real-world conditions using raters masked for type of antipsychotic. Thirty-eight patients were recruited, with 33 (86.8%) completing the trial. At week 12, clozapine was associated with significant improvement in the Positive and Negative Syndrome Scale (PANSS) total (p<0.0001), PANSS positive (p<0.0001), negative (p=0.0055) and general subscale scores (p<0.0001). Significant improvements occurred in all PANSS scores by week 4, the first post-baseline psychopathology rating. Altogether, 50.0% of patients showed ≥20% reduction in PANSS total score, 20.6% had ≥30% reduction and 14.7% had >40% reduction. Eighteen patients (47.4%) were discharged before week 12. However, all patients experienced ≥1 adverse event. Two of 38 patients (5.2%) dropped out due to moderate leucopenia and one of them developed agranulocytosis after stopping clozapine. However, both patients recovered. Eight adverse events (hypersalivation, fatigue, sedation, constipation, insomnia, nausea/vomiting, chest pain and leucopenia) were observed in 34-79% of patients. These findings suggest that clozapine is beneficial in Japanese treatment-resistant schizophrenia patients. However, attention should be paid to patients' adverse events.
UR - http://www.scopus.com/inward/record.url?scp=84877117177&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84877117177&partnerID=8YFLogxK
U2 - 10.1016/j.ajp.2012.10.007
DO - 10.1016/j.ajp.2012.10.007
M3 - Article
C2 - 23642976
AN - SCOPUS:84877117177
VL - 6
SP - 200
EP - 207
JO - Asian Journal of Psychiatry
JF - Asian Journal of Psychiatry
SN - 1876-2018
IS - 3
ER -