An open-label study of algorithm-based treatment versus treatment-as-usual for patients with schizophrenia

Jinichi Hirano,^1,2 Koichiro Watanabe,³ Takefumi Suzuki,^1,4 Hiroyuki Uchida,¹ Ryosuke Den,⁵ Taishiro Kishimoto,¹ Takashi Nagasawa,⁵ Yusuke Tomita,⁴ Koichiro Hara,⁶ Hiromi Ochi,⁷ Yoshimi Kobayashi,¹ Mutsuko Ishii,¹ Akane Fujita,¹ Yoshihiko Kanai,¹ Megumi Goto,¹ Hiromi Hayashi,¹ Kanako Inamura,¹ Fumiko Ooshima,¹ Mariko Sumida,¹ Tomoko Ozawa,¹ Kayoko Sekigawa,¹ Maki Nagaoka,¹ Kae Yoshimura,¹ Mika Konishi,¹ Ataru Inagaki,¹ Takuya Saito,⁸ Nobutaka Motohashi,⁹ Masaru Mimura,¹ Yoshiro Okubo,⁸ Motoichiro Kato,<sup>1

1</sup>Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan; ²Ohizumi Hospital, Tokyo, Japan; ³Department of Psychiatry School of Medicine, Kyorin University, Tokyo, Japan; ⁴Inokashira Hospital, Tokyo, Japan; ⁵Komagino Hospital, Tokyo, Japan; ⁶Asai Hospital, Chiba, Japan; ⁷Kurumegaoka Hospital, Tokyo, Japan; ⁸Department of Psychiatry School of Medicine, Nippon Medical School, Tokyo, Japan; ⁹Department of Psychiatry, School of Medicine, University of Yamanashi, Yamanashi, Japan

Objective: The use of an algorithm may facilitate measurement-based treatment and result in more rational therapy. We conducted a 1-year, open-label study to compare various outcomes of algorithm-based treatment (ALGO) for schizophrenia versus treatment-as-usual (TAU), for which evidence has been very scarce.
Methods: In ALGO, patients with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, fourth edition) were treated with an algorithm consisting of a series of antipsychotic monotherapies that was guided by the total scores in the positive and negative syndrome scale (PANSS). When posttreatment PANSS total scores were above 70% of those at baseline in the first and second stages, or above 80% in the 3rd stage, patients proceeded to the next treatment stage with different antipsychotics. In contrast, TAU represented the best clinical judgment by treating psychiatrists.
Results: Forty-two patients (21 females, 39.0 ± 10.9 years-old) participated in this study. The baseline PANSS total score indicated the presence of severe psychopathology and was significantly higher in the ALGO group (n = 25; 106.9 ± 20.0) than in the TAU group (n = 17; 92.2 ± 18.3) (P = 0.021). As a result of treatment, there were no significant differences in the PANSS reduction rates, premature attrition rates, as well as in a variety of other clinical measures between the groups. Despite an effort to make each group unique in pharmacologic treatment, it was found that pharmacotherapy in the TAU group eventually became similar in quality to that of the ALGO group.
Conclusion: While the results need to be carefully interpreted in light of a hard-to-distinguish treatment manner between the two groups and more studies are necessary, algorithm-based antipsychotic treatments for schizophrenia compared well to treatment-as-usual in this study.

Keywords: algorithm, open-label clinical trial, measurement-based treatment, schizophrenia, treatment-as-usual