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MAGZEN® Effect on Recent Anxiety Reaction (STRESS2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03602651
Recruitment Status : Completed
First Posted : July 27, 2018
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Laboratoire Dielen

Study Description
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Brief Summary:
Multicentres, observational study, prospective, to evaluate the effect of MAGZEN® in the treatment of recent anxiety reaction.

Condition or disease Intervention/treatment
Anxiety Disorders Other: Hamilton-anxiety scale (HAM-A)

Detailed 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.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Weeks
Official Title: MAGZEN® Effect on Recent Anxiety Reaction (STRESS2)
Actual Study Start Date : November 8, 2019
Actual Primary Completion Date : May 3, 2021
Actual Study Completion Date : May 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Groups and Cohorts
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Group/Cohort Intervention/treatment
MAGZEN®
All patient will be treated with MAGZEN® and will be evaluated with the Hamilton-anxiety scale (HAM-A)
 Other: Hamilton-anxiety scale (HAM-A)
Evolution of anxiety disorders is evaluated by the Hamilton-anxiety scale (HAM-A)


Outcome Measures
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Primary Outcome Measures :
  1. number of "responders patients" [ Time Frame: 4 weeks ]
    number (%) of "responders patients" with a diminution of the HAM-A score ≥ 50 %


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients suffuring from a recent anxiety reaction not already treated.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602651


Locations
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France
Private practice
Marseille, France
Sponsors and Collaborators
Laboratoire Dielen
Investigators
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Study Chair: Frédéric MD ROUILLON Hôpital St Anne
More Information
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Additional Information:

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Responsible Party: Laboratoire Dielen
ClinicalTrials.gov Identifier: NCT03602651    
Other Study ID Numbers: N°ID-RCB : 2018-A01516-49
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders