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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Major Depression

Intervention / Treatment
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* Biological: botulinum toxin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: corrugator<br>single injection of 10 Units of botulinum toxina in the corrugator and procerus | Biological: botulinum toxin<br>* injection of botulinum toxina in two different facial sites<br>|
| Active Comparator: orbicularis oculi<br>single injection of 10 Units of botulinum toxina in the lateral muscle orbicularis oculi (involved in crow's feet wrinkles) | Biological: botulinum toxin<br>* injection of botulinum toxina in two different facial sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |