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Clinical Trials/NCT03602651
NCT03602651CompletedNot Applicable

MAGZEN® Effect on Recent Anxiety Reaction (STRESS2)

Laboratoire Dielen1 site in 1 country110 target enrollmentStarted: November 8, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
110
Locations
1
Primary Endpoint
number of "responders patients"

Study Overview

Brief Summary

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

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
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

number of "responders patients"

Time Frame: 4 weeks

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Laboratoire Dielen
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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