Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Major Depression
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 impossiblePrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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...
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).
Tracking Information
- NCT #
- NCT03484754
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Eric Charles, MD Centre Hospitalier Esquirol Study Director: Danièle Ranoux, MD, PhD University Hospital, Limoges
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