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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03602651
Other study ID # N°ID-RCB : 2018-A01516-49
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 8, 2019
Est. completion date May 14, 2021

Study information

Verified date August 2021
Source Laboratoire Dielen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Multicentres, observational study, prospective, to evaluate the effect of MAGZEN® in the treatment of recent anxiety reaction.


Description:

107 patients suffering from recent anxiety reaction will be included in the study. They will be treated by MAGZEN® during 4 weeks and we will study the effect of this treatment on the evolution of their anxiety after the cure.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date May 14, 2021
Est. primary completion date May 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - patient suffering from recent anxiety reaction - Hamilton-anxiety score = 20 at inclusion - recent anxiety disorders (less than 3 months) not treated by pharmacological or psychological treatment Exclusion Criteria: - major depressive syndrome - anxiety disorders more than 3 months - anxiety due to death

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hamilton-anxiety scale (HAM-A)
Evolution of anxiety disorders is evaluated by the Hamilton-anxiety scale (HAM-A)

Locations

Country Name City State
France Private practice Marseille

Sponsors (1)

Lead Sponsor Collaborator
Laboratoire Dielen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of "responders patients" number (%) of "responders patients" with a diminution of the HAM-A score = 50 % 4 weeks
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