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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    58
  • sponsor
    Centre Hospitalier Esquirol
Updated on 10 October 2021
remission
depression
antidepressants
depressive episode

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).

Details
Condition Major depression, Endogenous depression, major depressive disorder, major depressive disorders
Treatment Botulinum Toxin
Clinical Study IdentifierNCT03484754
SponsorCentre Hospitalier Esquirol
Last Modified on10 October 2021

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