NCT03484754

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Centre Hospitalier Esquirol · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Major Depression

Interventions

Type	Name	Description
BIOLOGICAL	botulinum toxin	injection of botulinum toxina in two different facial sites

Timeline

• Start date: 2018-04-01
• Primary completion: 2021-07-30
• Completion: 2021-12-31
• First posted: 2018-04-02
• Last updated: 2021-10-05

Locations

1 site across 1 country: France