MAGZEN® Effect on Recent Anxiety Reaction (STRESS2)

MAGZEN® Effect on Recent Anxiety Reaction (STRESS2)

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

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Private Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients suffuring from a recent anxiety reaction not already treated.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of "responders patients"	number (%) of "responders patients" with a diminution of the HAM-A score ≥ 50 %	4 weeks

Collaborators and Investigators

• Sponsor: Laboratoire Dielen
• Investigators: Study Chair: Frédéric MD ROUILLON, Hôpital St Anne

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2019
• Primary Completion (Actual): May 3, 2021
• Study Completion (Actual): May 14, 2021

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: N°ID-RCB : 2018-A01516-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No