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

Centre Hospitalier Esquirol

Status

Unknown

Conditions

Major Depression

Treatments

Biological: botulinum toxin

Study type

Interventional

Funder types

Other

Identifiers

NCT03484754

2017-A0392-51

Details and patient eligibility

About

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.

Full 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).

Enrollment

58 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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