Comparison of the efficacy of a treatment for anxiety with Passiflore Compose (homeopathic treatment) and benzodiazepine, alprazolam (drug therapy).

Phase 1

• Conditions: Adjustment disorder with anxiety; MedDRA version: 20.0 Level: HLGT Classification code 10002861 Term: Anxiety disorders and symptoms System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2017-002263-17-FR
• Lead Sponsor: BOIRO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-16
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 282

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

- 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 ;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified