| Co-Investigator(Kenkyū-buntansha) |
SUGIHARA Gennichi Hamamatsu University School of Medicine, Osaka Hamamatsu Joint Research Center for Child Mental Development, Assistant Professor (70402261)
MATSUZAKI Hideo Osaka University, Osaka Hamamatsu Joint Research Center fix Child Mental Development, Associate Professor (00334970)
TAKEBAYASHI Akikazu Hamamatsu University School of Medicine, University Hospital, Assistant Professor (50397428)
HASHIMOTO Takanori Kanazawa University, Graduate School of Medicine, Associate Professor (40249959)
KIKUCHI Mitsuru Kanazawa University, Hospital, Assistant Professor (00377384)
関根 吉統 浜松医科大学, 医学部, 助手 (70324358)
中村 和彦 浜松医科大学, 医学部附属病院, 講師 (80263911)
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| Budget Amount *help |
¥16,450,000 (Direct Cost: ¥15,100,000、Indirect Cost: ¥1,350,000)
Fiscal Year 2007: ¥5,850,000 (Direct Cost: ¥4,500,000、Indirect Cost: ¥1,350,000)
Fiscal Year 2006: ¥10,600,000 (Direct Cost: ¥10,600,000)
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| Research Abstract |
Method. Patients were included in the study if they: 1) were age 18-50 years, met the DSM-IV criteria for schizophrenia as assessed with the Structured Clinical Interview for DSM-IV, Research Version (SCID-RV); 2)were treated with a stable-dose of risperidone, raging 2 to 6mg, for more than 8 weeks; 3) had a score 〓15 on negative subscale items in Positive and Negative Syndrome Scale (PANSS), 4)had a minimum period of symptom stability, defined as no more than 20% change on consecutive ratings on PANSS for at lease 4 weeks. Subjects entered a 8-weeks, double-blind treatment phase during which they were randomly assigned to receive either pergolide or placebo, which was added to risperidone treatment. Pergolide was started at a daily dose of 250 μg for I week and increased to 750 μg from the second week, continuing for total of 8 weeks. The study medication and placebo were provided in identically appearing capsules. The PANSS was used to assess the severity of psychiatric symptoms, and
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the Quality of Life Scale (QLS) abbreviated version was used to measure general social functioning. Extrapyramidal symptoms, akathisia, and dyskinesia, were evaluated by the Simpson-Angus Rating Scale for Extrapyramidal Symptoms, the Barnes Akathisia Scale, and the Abnormal Involuntary Movement Scale. Estimates of premorbid and current intellectual functions were made by Japanese version of National Adult Reading Test(JART)and short form of Wechsler Adult Intelligence Scale-Revised(WAIS-R). Patients were tested on a comprehensive neuropsychological test battery: executive function, spatial working memory, sustained attention, verbal memory, verbal working memory, verbal fluency. Premorbid and current intellectual functions were measured at the baseline. Results. Twenty-six subjects were randomized to either pergolide or placebo (13 pergolide, 13 placebo; mean age t SD, 33.9 t 5.5 in pergolide, 37.2 ± 8.4 in placebo). Twenty-two subjects completed the entire protocol. No significant differences were noted between the PANSS total, positive scale, and negative scale scores between groups at baseline. Repeated-measures ANOVA revealed no significant differences between pergolide and placebo treatment groups during 8 weeks of the study with respect to PANSS total, PANSS positive, PANSS negative, and QLS scores. There were no statistically significant differences in change(from baseline to week 8)on any of the cognitive measures between the placebo and pergolide treated groups. Less
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