Table 2.
Clinical trials using yokukansan for patients with schizophrenia and schizophrenia-like psychosis
| Study, year | Sample size and study design | Average daily dosage (g/day) mean ± standard deviation | Assessment | Adverse events |
|---|---|---|---|---|
| Miyaoka,33 2008 | 13 males 9 females Mean age: 57.1 years 12-week open-label study Adjunctive therapy |
7.5 | AIMS (12.1±2.2–>1.6±1.3)** PANSS: Positive (22.2±4.2–>16.6±3.1)** Negative (26.5±6.3–>14.5±2.3)** General (42.9±6.7–>25.0±4.9)** CGI-S (4.86±0.9–>1.73±0.6)** |
Nausea and constipation (2 cases) |
| Miyaoka,34 2009 | Treatment group 16 males 18 females Mean age: 45.5 years Control group 10 males 15 females Mean age: 45.2 years 4-week open-label control study Adjunctive therapy |
6.7±2.5 | PANSS: Positive (27.7±6.1–>11.9±3.7)** Negative (30.4±5.8–>18.2±2.2)** General (65.1±5.4–>39.6±6.9)** DIEPSS (7.8±4.7–>6.9±4.1) |
Nausea (2 cases) Tiredness (1 case) |
| Miyaoka,35 2009 | A 2-week-treatment case report Monotherapy |
7.5 | Self-report | No adverse events reported |
| Miyaoka,36 2011 | 7 males 13 females Mean age: 66.3 years 4-week open-label study Monotherapy |
5.8±2.6 | NPI (20.4±2.4–>5.4±1.5)** HS-PANSS (6.4±2.4–>1.6±1.2)** CGI (4.5±1.8–>1.3±0.3)** |
Nausea (3 cases) |
| Miyaoka,38 2013 | 20 males 20 females Mean age: 73.1 years 4-week open-label study Monotherapy |
Baseline 5.02±1.06 week 4 5.23±1.22 |
BPRS (36.7±4.65–>20.1±1.6)* CGI-S (5.03±0.89–>1.73±0.55)* PANSS (66.0±7.3–>34.3±2.2)* Simpson-Angus Scale (0.27±0.45–>0.15±0.36) Barnes Akathisia Rating Scale (0.20±0.41–>0.13±0.34) AIMS (0.23±0.42–>0.18±0.39) |
Tremor (3 cases) |
Notes:
*
P<0.001,
**
P<0.0001.
Abbreviations: AIMS, Abnormal Involuntary Movement Scale; BPRS, Brief Psychiatric Rating Scale; CGI, Clinical Global Impression; CGI-S, CGI-Severity; DIEPSS, Drug-Induced Extrapyramidal Symptom Scale; HS-PANSS, hallucination subscale of the PANSS; NPI, Neuropsychiatric Inventory; PANSS, Positive and Negative Symptom Scale.