Status:
UNKNOWN
Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites.
Lead Sponsor:
Centre Hospitalier Esquirol
Conditions:
Major Depression
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ...
Detailed 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 significan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03484754
Start Date
April 1 2018
End Date
December 31 2021
Last Update
October 5 2021
Active Locations (1)
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1
Centre Hospitalier esquirol
Limoges, France, 87000