Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites at Three Months.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- proportion of patients with improvement of depressive symptoms based on the evolution of the MADRS scale
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
blinding impossible
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
proportion of patients with improvement of depressive symptoms based on the evolution of the MADRS scale
时间窗: 6 weeks
≥ 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)
次要结局
未报告次要终点
研究者
Eric Charles
principal investigator
Centre Hospitalier Esquirol