向精神薬の臨床評価 : Thienodiazepine誘導体Y-6047の心身症・神経症に対する二重盲検比較試験

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A double-binf controlled study was conducted to evaluate clinical efficacy and safety of a new thienodiazepine derivative (Y-6047) on neurotics and psychosomatic disorders.One hundred and thirty-eight patients were randomly divided into three groups : forty-five of them were administered Y-6047 as an investigational drug, forty-eight diazepam as a standard drug and forty-five placebo as a control. Thirty patients dropped our : six from Y-6047 group, twelve from diazepam group and twelve from placebo group respectively.After one week of wash-out period, two weeks of drug administration period followed. In the first week of drug administration, 15mg of Y-6047,6 mg of diazepam or 3 tables of placebo daily was given. In the second week, flexible schedule was planned, ranging from 15mg to 30mg of Y-6047,6mg to 9mg of diazepam.The results obtained were as follows;1. Global judgement : percentages of patients with excellent and moderate improvement were 56% for Y-6047 group, 53% for diazepam group and 42% for placebo group respectively.2. Main target symptoms of Y-6047 were anxiety, tension, irritability, insomnia, depressive mood fatiguability, palpitation and poor appetite.3. Side effects : one of dizziness and three of drawsiness in Y-6047 group, one of dizziness and two of drawsiness in diazepam group, three of dizziness, one of drawsiness and one of shakiness in placebo group were reported.4. No abnormal laboratory findings caused by or related to the drug were reported.
日本心身医学会の論文
1974-08-01

向精神薬の臨床評価 : Thienodiazepine誘導体Y-6047の心身症・神経症に対する二重盲検比較試験

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