STRESS2: MAGZEN® Effect on Recent Anxiety Reaction

• Sponsor: Laboratoire Dielen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03602651
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Actual Duration (Months): 18.2
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 110 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: MAGZEN® Effect on Recent Anxiety Reaction (STRESS2)
• Actual Study Start Date: Nov 8, 2019
• Actual Primary Completion Date: May 3, 2021
• Actual Study Completion Date: May 14, 2021

Arms and Interventions

Arm	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

Primary Outcome Measures

1. number of "responders patients" [4 weeks]

   number (%) of "responders patients" with a diminution of the HAM-A score ≥ 50 %

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Private practice	Marseille		France

Sponsors and Collaborators

• Laboratoire Dielen

Investigators

• Study Chair: Frédéric MD ROUILLON, Hôpital St Anne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratoire Dielen
• ClinicalTrials.gov Identifier: NCT03602651
• Other Study ID Numbers: N°ID-RCB : 2018-A01516-49
• First Posted: Jul 27, 2018
• Last Update Posted: Aug 20, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Aug 20, 2021