TY - JOUR
T1 - Study protocol
T2 - Safety correction of high dose antipsychotic polypharmacy in Japan
AU - Sukegawa, Tsuruhei
AU - Inagaki, Ataru
AU - Yamanouchi, Yoshio
AU - Inada, Toshiya
AU - Yoshio, Takashi
AU - Yoshimura, Reiji
AU - Iwata, Nakao
N1 - Funding Information:
We are grateful to the members of the national project team supported by a research grant for nervous and mental disorders from the Ministry of Health, Labour and Welfare, Japan (from 2001 to 2012). We are also grateful to the 56 centers that participated in the SCAP study. In the following 15 centers, the protocol was approved by each institution’s own Ethics Review Board: Asahi Hospital, Atago Hospital, Fujita Health University School of Medicine, HigashiowariHospital, Kurayoshi Hospital, Kyowa Hospital, Ryukyu Hospital, Seijuji Hospital, Seiwa Hospital (Institute of Neuropsychiatry), Seiwa Hospital (Seiunkai), Shin-abuyama Hospital, Shizuoka Psychiatric Medical Center, Tottori Medical Center, Yamanashi Prefectural Kita Hospital and Watarigawa Hospital. In the following 41 centers, the protocol was approved by the Ethics Review Board of Fujita Health University: Amekudai Hospital, Dazaifu Hospital, Hayashi Hospital, Hiagari Hospital, Hino Hospital, Hiratsuka Hospital, Hokuriku Hospital, Hotei Hospital, Ichiyo Hospital, Ishibashi Hospital, Izumihara Hospital, Jikei-chuo Hospital, Jindai Hospital, Kariya Hospital, Katsushika Hospital, Kawada Hospital, Komine-eto Hospital, Kurono Hospital, Meisei Hospital, Minamigaoka Hospital, Morimoto Hospital, Musashino Chuo Hospital, Nagano Prefectural mental wellness center Komagane, Nishikawa Hospital, Numazu Central Hospital, Oitashimogori Hospital, Okehazama Hospital, Rainbow & Sea Hospital, Sagatasou, Saigata Hospital, Sanmaibashi Hospital, Sanyo Hospital, Shioiri Mental Clinic, Sumiyoshi Hospital, Takamatsu Hospital, Tokiwa Hospital, Tokyo-ome Hospital, Tosa Hospital, Tsukubahigashi Hospital, Yahatakousei Hospital and Wakakusa Hospital.
Funding Information:
10. Murasugi K, Hagiwara T, Shouda S: Attempt to Correct Antipsychotic Administration to Monotherapy and Dose Reduction for Chronic Schizophrenia Patients. In Development of the Treatment and Rehabilitation Guideline for Schizophrenia and the Demonstration Study of its Effectiveness: Final Report of the National Project Team, Supported by the Research Grant for Nervous and Mental Disorders from the Ministry of Health, Labour and Welfare, Japan in 2001. Edited by Urata J. Japan: National Project Team, Supported by the Research Grant for Nervous and Mental Disorders from the Ministry of Health, Labour and Welfare; 2004:67–73. in Japanese.
PY - 2014/4/7
Y1 - 2014/4/7
N2 - Background: In Japan, combination therapy with high doses of antipsychotic drugs is common, but as a consequence, many patients with schizophrenia report extrapyramidal and autonomic nervous system side effects. To resolve this, we proposed a method of safety correction of high dose antipsychotic polypharmacy (the SCAP method), in which the initial total dose of all antipsychotic drugs is calculated and converted to a chlorpromazine equivalent (expressed as milligrams of chlorpromazine, mg CP). The doses of low-potency antipsychotic drugs are then reduced by ≤ 25 mg CP/week, and the doses of high-potency antipsychotics are decreased at a rate of ≤50 mg CP/week. Although a randomized, case-controlled comparative study has demonstrated the safety of this method, the number of participants was relatively small and its results required further validation. In this study of the SCAP method, we aimed to substantially increase the number of participants.Methods/design: The participants were in- or outpatients treated with two or more antipsychotics at doses of 500-1,500 mg CP/day. Consenting participants were randomized into control and dose reduction groups. In the control group, patients continued with their normal regimen for 3 months without a dose change before undergoing the SCAP protocol. The dose reduction group followed the SCAP strategy over 3-6 months with a subsequent 3-month follow-up period. Outcome measures were measured at baseline and then at 3-month intervals, and included clinical symptoms measured on the Manchester scale, the extent of extrapyramidal and autonomic side effects, and quality of life using the Euro QOL scale. We also measured blood drug concentrations and drug efficacy-associated biochemical parameters. The Brief Assessment of Cognition in Schizophrenia, Japanese version, was also undertaken in centers where it was available.Discussion: The safety and efficacy of the SCAP method required further validation in a large randomized trial. The design of this study aimed to address some of the limitations of the previous case-controlled study, to build a more robust evidence base to assist clinicians in their efforts to reduce potentially harmful polypharmacy in this vulnerable group of patients.
AB - Background: In Japan, combination therapy with high doses of antipsychotic drugs is common, but as a consequence, many patients with schizophrenia report extrapyramidal and autonomic nervous system side effects. To resolve this, we proposed a method of safety correction of high dose antipsychotic polypharmacy (the SCAP method), in which the initial total dose of all antipsychotic drugs is calculated and converted to a chlorpromazine equivalent (expressed as milligrams of chlorpromazine, mg CP). The doses of low-potency antipsychotic drugs are then reduced by ≤ 25 mg CP/week, and the doses of high-potency antipsychotics are decreased at a rate of ≤50 mg CP/week. Although a randomized, case-controlled comparative study has demonstrated the safety of this method, the number of participants was relatively small and its results required further validation. In this study of the SCAP method, we aimed to substantially increase the number of participants.Methods/design: The participants were in- or outpatients treated with two or more antipsychotics at doses of 500-1,500 mg CP/day. Consenting participants were randomized into control and dose reduction groups. In the control group, patients continued with their normal regimen for 3 months without a dose change before undergoing the SCAP protocol. The dose reduction group followed the SCAP strategy over 3-6 months with a subsequent 3-month follow-up period. Outcome measures were measured at baseline and then at 3-month intervals, and included clinical symptoms measured on the Manchester scale, the extent of extrapyramidal and autonomic side effects, and quality of life using the Euro QOL scale. We also measured blood drug concentrations and drug efficacy-associated biochemical parameters. The Brief Assessment of Cognition in Schizophrenia, Japanese version, was also undertaken in centers where it was available.Discussion: The safety and efficacy of the SCAP method required further validation in a large randomized trial. The design of this study aimed to address some of the limitations of the previous case-controlled study, to build a more robust evidence base to assist clinicians in their efforts to reduce potentially harmful polypharmacy in this vulnerable group of patients.
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U2 - 10.1186/1471-244X-14-103
DO - 10.1186/1471-244X-14-103
M3 - Article
C2 - 24708857
AN - SCOPUS:84899476915
SN - 1471-244X
VL - 14
JO - BMC Psychiatry
JF - BMC Psychiatry
IS - 1
M1 - 103
ER -