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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| corrugator | Experimental | single injection of 10 Units of botulinum toxina in the corrugator and procerus |
|
| orbicularis oculi | Active Comparator | single injection of 10 Units of botulinum toxina in the lateral muscle orbicularis oculi (involved in crow's feet wrinkles) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin | Biological | injection of botulinum toxina in two different facial sites |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Charles, MD | Centre Hospitalier Esquirol | Principal Investigator |
| Danièle Ranoux, MD, PhD | University Hospital, Limoges | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier esquirol | Limoges | 87000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40226647 | Derived | Ceolato-Martin C, Chevallier-Collins C, Clement JP, Charles E, Lacroix A, Ranoux D. OnabotulinumtoxinA in Resistant Depression: A Randomized Trial Comparing Two Facial Injection Sites (OnaDEP Study). Depress Anxiety. 2024 Sep 12;2024:1177925. doi: 10.1155/2024/1177925. eCollection 2024. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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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.
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blinding impossible
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| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |