In order to determine the effectiveness of Orengedoku-to in the treatment of schizophrenia, Orengedoku-to was added to the drug regimens of 10 patients who had been hospitalized with onset episodes or acute exacerbation of this condition. Before Orengedoku-to was added, the schizophrenic symptoms associated with the active phase had already been ameliorated with administration of antipsychotic drugs such as haloperidol for 4-12 weeks, with administration continuing at least two weeks after these symptoms had stabilized. Symptoms were evaluated using the Brief Psychiatric Rating Scale (BPRS) three times: before Orengedoku-to was added, immediately following cessation of administration, and four weeks after administration had ended. The BPRS scores indicated significant decreases both immediately following cessation of administration and four weeks later (from 36.3±9.8 to 30.5±6.7). In particular, significant improvement was noted for the symptoms of guilt feelings, depressive mood, suspiciousness and excitement. These improvements were not thought to be due to haloperidol, because the plasma haloperridol levels did not change. No adverse effects were noted.

Eighteen untreated patients with schizophrenia and other psychotic disorders, all of whom had insomnia among their chief complaints, were randomly divided into two groups. For four weeks, nine patients (group A) were treated with neuroleptics (haloperidol) and Orengedokuto, and the remainder (group B) were treated with neuroleptics alone. Changes in schizophrenic symptoms and the number of doses of hypnotics (nitrazepam) were examined. In group A, the thought disturbance (conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content) aspect of schizophrenic symptoms improved (p=0.06), and the number of doses of hypnotics (mean=1.9) was smaller (p=0.06), as compared with group B (mean=7.7). These observations suggest that augmentation therapy with Orengedoku-to is potentially effective for the treatment of insomnia associated with schizophrenia and other psychotic disorders.