This study used a cross-sectional design in a consecutive sample of 122 Japanese patients with schizophrenia (10 inpatients, 112 outpatients; 51 men, 71 women; mean age ± standard deviation, 43.2 ± 13.5 years) who were treated at Fujisawa Hospital, Asahinooka Hospital, or Yokohama City University Hospital in Japan from June 2016 to August 2019. All patients had received oral aripiprazole as monotherapy or AOM as monotherapy for more than 3 months at the same dosage and without adjustment in the previous 3 months. Fifty-two patients in the oral aripiprazole group and 9 patients in the AOM group were those involved in our previous study [9 (link), 23 (link)]. In addition, patients with schizophrenia receiving oral aripiprazole or AOM were newly recruited for the present study. Exclusion criteria were as follows: nonadherence to medication prescribed (evaluated using medical interviews); current or previous cardiovascular, respiratory, neurological, or endocrine illness; and current or previous substance abuse that could obscure diagnosis. Patients taking non-psychotropic medications such as antihypertensive drugs other than laxatives, which do not affect HRV, were excluded. Psychiatrists with sufficient clinical experience made the diagnosis of schizophrenia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition [24 ]. They also evaluated patients’ positive, negative, and general signs using a Japanese translation of the Positive and Negative Syndrome Scale (PANSS; [25 (link)]) to determine symptom severity on the same day as an electrocardiogram (ECG) was recorded.
We collected participants’ clinical information from the medical records and calculated the doses of all psychotropic medications prescribed, including aripiprazole, anticholinergic, and benzodiazepine agents, using conversions to standard equivalents of chlorpromazine, biperiden, and diazepam [26 (link)].
This study was approved by respective ethics committees of Fujisawa Hospital, Asahinooka Hospital, and Yokohama City University Hospital and was conducted in accordance with the Declaration of Helsinki. Informed consent was obtained from all participants following a full explanation of the study.
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