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

Major Depression Clinical Trial

— OnaDEP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03484754
• Other study ID #: 2017-A0392-51
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: Centre Hospitalier Esquirol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: December 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Major Depression

Intervention

Biological:
• botulinum toxin
injection of botulinum toxina in two different facial sites

Locations

Country	Name	City	State
France	Centre Hospitalier esquirol	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Esquirol

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 weeks