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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Major Depression
• Intervention / Treatment: Biological: botulinum toxin

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 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).

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87000
    • Centre Hospitalier Esquirol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Esquirol
• Investigators: Principal Investigator: Eric Charles, MD, Centre Hospitalier Esquirol; Study Director: Danièle Ranoux, MD, PhD, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): July 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 2017-A0392-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No