Efficacy and safety of Passiflora Compose in patients newly diagnosed with adjustment disorder with anxiety, as first-line treatment, compared to alprazolam - PASSIANCE

BOIRO0 个研究点目标入组 282 人开始时间: 2018年1月16日最近更新: 2019年12月10日

试验速览

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•- Age = 18 and = 70 years ;
•- Patient having adjustment disorder with anxiety or trait anxiety ;
•- Hamilton score scale-anxiety (HAM-A) = 18 at inclusion ;
•- Recent anxiety (inferior or equals to 3 months), with no pharmacological or psychological treatment ;
•- Disorders needing prescription of anxiolytic treatment with homeopathic medicine or benzodiazepine according to the doctor ;
•- Patient unable to understand informations about study , to read information sheet and accepting to sign the informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 270
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•- Patient with anxiety disorder other than adjustment disorder with anxiety, major depressive disorder or all other mental pathology ;
•- Anxiety related to bereavement ;
•- Anxiety felt more than 3 months ;
•- Patient treated for anxiety with psychtropic substances or with psychotherapy in the last 3 months ;
•- History of alcohol abuse or drug abuse ;
•- Pregnancy or lactation, woman of childbearing potential not using a medically acceptable, highly effective
•method of birth control ;
•- Known hypersensitivity to one of the components of the study or contra-indication to one of the treatments ;
•- Participation in another clinical study or at exclusion period for another clinical trial ;

发起方

BOIRO