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
Study Sites (1)
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