MAGZEN® Effect on Recent Anxiety Reaction | NCT03602651

Studies
MAGZEN® Effect on Recent Anxiety Reaction

NCT03602651

Sponsor

Laboratoire Dielen

Status

Completed

Last Update Posted

Aug 20, 2021Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Anxiety Disorders

Interventions

Hamilton-anxiety scale (HAM-A)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2019Actual

Primary Completion Date

May 3, 2021Actual

Completion Date

May 14, 2021Actual

First Submitted Date

Jul 18, 2018

First Submission Date that Met QC Criteria

Jul 18, 2018

First Posted Date

Jul 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2021

Last Update Posted Date

Aug 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hamilton-anxiety scale (HAM-A)	Other	Evolution of anxiety disorders is evaluated by the Hamilton-anxiety scale (HAM-A)	MAGZEN®

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frédéric MD ROUILLON	Hôpital St Anne	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Private practice		Marseille			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided