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

NCT03484754 | Unknown

• 1 other identifier: 2017-A0392-51
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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 of the crow's feet area, in addition to the current antidepressant treatment.

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

corrugator

EXPERIMENTAL

single injection of 10 Units of botulinum toxina in the corrugator and procerus

Biological: botulinum toxin

orbicularis oculi

ACTIVE COMPARATOR

single injection of 10 Units of botulinum toxina in the lateral muscle orbicularis oculi (involved in crow's feet wrinkles)

Biological: botulinum toxin

Interventions

botulinum toxin BIOLOGICAL

injection of botulinum toxina in two different facial sites

corrugator; orbicularis oculi

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Esquirol: lead

Study Sites (1)

Centre Hospitalier esquirol

Limoges, 87000, France

Location

Related Publications (1)

• 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.

  PMID: 40226647 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Eric Charles, MD

  Centre Hospitalier Esquirol

  PRINCIPAL INVESTIGATOR

• Danièle Ranoux, MD, PhD

  University Hospital, Limoges

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: blinding impossible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: April 1, 2018
• Primary Completion: July 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)