Adjustment disorder with anxiety MedDRA version: 20.0 Level: HLGT Classification code 10002861 Term: Anxiety disorders and symptoms System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Passiflore Compose
Product Name: Passiflore compose
Pharmaceutical Form: Granules
Pharmaceutical form of the placebo: Granules
Sponsors
BOIRON
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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 ;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to demonstrate the non inferiority of PC in comparison to alprazolam in anxiety disorders after 4 weeks of treatment (efficacy objective).; Secondary Objective: The secondary objectives are : - Efficacy : o To evaluate the rate of responders to the treatment for anxiety or in remission of anxiety ; o to evaluate the evolution of anxiety component during treatment ; o to evaluate the evolution of the sleep disorders during treatment ; - Safety : o to evaluate changing in prescription during the follow-up ; o to evaluate the concomitant use of medicine ; o to evaluate the safety drug ; o to evaluate the rebound effect after stopping drug ; - Others : o to evaluate the evolution of the functional capacity of the patient during treatment ; o to evaluate the general impression of the doctor and of the patient for symptoms and the evolution of symptoms ; o to evaluate the treatment compliance. ;Primary end point(s): The main objective is to evaluate the non inferiority of PC compared to APZ with the HAM-A score at V2.;Timepoint(s) of evaluation of this end point: At 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At 4 weeks; Secondary end point(s): The secondary efficacy analysis are : o the rates of responders to the teatment and the rates of remission in anxiety o the evolutions of the total anxiety score and of the components during treatment o the evolution of the quality of sleep between V0 and V2 | — |
Countries
France
Contacts
Public ContactChargée d'Affaires Réglementaires
EURAXI PHARMA
Outcome results
None listed