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Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites. (OnaDEP)

Primary Purpose

Major Depression

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
botulinum toxin
Sponsored by
Centre Hospitalier Esquirol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female from 18 to 80 years old included
  • Inpatient or ambulatory patients treated for resistant depressive episode, that is to say by an absence of symptomatic remission (nonresponse or partial response) after the use of two successive trials of antidepressants of different pharmacological class, well conducted in terms of dosage and duration, while ensuring quality adherence (at least 80% of the treatment taken during the period considered)
  • Diagnosis according to DSM-5 depressive episode characterized with MADRS score> 20
  • Women of childbearing potential must have an effective method of contraception (failure rate <1% per year with correct use): IUD, pill, ... (participant statement)
  • Patient able to adhere to the restrictions and prohibitions of the protocol
  • Patient agreeing to sign an informed consent

Exclusion Criteria:

  • Current psychiatric comorbidity
  • Severe intellectual disability
  • Known hypersensitivity to botulinum toxin type A or any of the excipients
  • Myasthenia gravis
  • Presence of infection at the injection site (s)
  • Participation in an interventional clinical study.
  • Pregnant woman, breastfeeding, or who plans to be pregnant during the study or within 6 weeks after the last administration of the treatment.
  • Any patient already receiving aesthetic treatment

Sites / Locations

  • Centre Hospitalier esquirol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

corrugator

orbicularis oculi

Arm Description

single injection of 10 Units of botulinum toxina in the corrugator and procerus

single injection of 10 Units of botulinum toxina in the lateral muscle orbicularis oculi (involved in crow's feet wrinkles)

Outcomes

Primary Outcome Measures

proportion of patients with improvement of depressive symptoms based on the evolution of the MADRS scale
≥ 50% decrease from baseline of the MADRS score will be considered as improvement (Montgomery and Asberg depression rating scale - total score = 60 points for maximum depression)

Secondary Outcome Measures

Full Information

First Posted
March 26, 2018
Last Updated
October 4, 2021
Sponsor
Centre Hospitalier Esquirol
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1. Study Identification

Unique Protocol Identification Number
NCT03484754
Brief Title
Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites.
Acronym
OnaDEP
Official Title
Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites at Three Months.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Esquirol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to evaluate in adult subjects with resistant depression the effect of an injection of botulinum toxin in the corrugator and procerus muscles, in comparison to the infiltration of the crow's feet area, in addition to the current antidepressant treatment.
Detailed Description
Three randomized, double-blind, placebo-controlled studies have shown that a single injection of OnaBotulinum Toxin A (OnaA) into the corrugator and procerus (frowning muscles) allows for a significant decrease in patients with a depressive episode characterized resistant. However, the effectiveness of this method of treating depression can not currently be considered established. The main objective of our study is therefore to evaluate the efficacy of OnaA injections in the glabellar zone with a different methodology, using lateral muscle injection orbicularis oculi (involved in crow's feet wrinkles). ) as another injection zone in comparison. The efficacy will correspond to the number of responders at 6 weeks in the two groups of injection. This evaluation will be done at 6 weeks, then at 3 months (S12).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The main pitfall of these studies is indeed the difficulty in ensuring a double-blind when the TB is injected into the corrugator and the procerus with placebo as physiological saline, since the patient as the examiner can guess which product was administered. The main objective of our study is therefore to evaluate the efficacy of OnaA injections in the glabellar zone , using lateral muscle injection orbicularis oculi (involved in crow's feet wrinkles) as another injection zone in comparison.
Masking
None (Open Label)
Masking Description
blinding impossible
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
corrugator
Arm Type
Experimental
Arm Description
single injection of 10 Units of botulinum toxina in the corrugator and procerus
Arm Title
orbicularis oculi
Arm Type
Active Comparator
Arm Description
single injection of 10 Units of botulinum toxina in the lateral muscle orbicularis oculi (involved in crow's feet wrinkles)
Intervention Type
Biological
Intervention Name(s)
botulinum toxin
Intervention Description
injection of botulinum toxina in two different facial sites
Primary Outcome Measure Information:
Title
proportion of patients with improvement of depressive symptoms based on the evolution of the MADRS scale
Description
≥ 50% decrease from baseline of the MADRS score will be considered as improvement (Montgomery and Asberg depression rating scale - total score = 60 points for maximum depression)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female from 18 to 80 years old included Inpatient or ambulatory patients treated for resistant depressive episode, that is to say by an absence of symptomatic remission (nonresponse or partial response) after the use of two successive trials of antidepressants of different pharmacological class, well conducted in terms of dosage and duration, while ensuring quality adherence (at least 80% of the treatment taken during the period considered) Diagnosis according to DSM-5 depressive episode characterized with MADRS score> 20 Women of childbearing potential must have an effective method of contraception (failure rate <1% per year with correct use): IUD, pill, ... (participant statement) Patient able to adhere to the restrictions and prohibitions of the protocol Patient agreeing to sign an informed consent Exclusion Criteria: Current psychiatric comorbidity Severe intellectual disability Known hypersensitivity to botulinum toxin type A or any of the excipients Myasthenia gravis Presence of infection at the injection site (s) Participation in an interventional clinical study. Pregnant woman, breastfeeding, or who plans to be pregnant during the study or within 6 weeks after the last administration of the treatment. Any patient already receiving aesthetic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Charles, MD
Organizational Affiliation
Centre Hospitalier Esquirol
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Danièle Ranoux, MD, PhD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier esquirol
City
Limoges
ZIP/Postal Code
87000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites.

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