Major DepressionOnaDEPNCT03484754
Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites.
A study testing botulinum toxin in people with Major Depression, run by Centre Hospitalier Esquirol at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depression
- What is being tested?
- botulinum toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Major Depression
- Being tested
- botulinum toxin
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxinBiological
injection of botulinum toxina in two different facial sites
| Study group | Role | What they receive |
|---|---|---|
| corrugator | Experimental | single injection of 10 Units of botulinum toxina in the corrugator and procerus Receives: 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) Receives: Biological: botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Apr 2018
- Primary completion30 Jul 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Charles, Centre Hospitalier Esquirol
- Investigators
- Eric Charles, MD, Principal investigator, Centre Hospitalier EsquirolDanièle Ranoux, MD, PhD, Study director, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484754
- Sponsor's protocol ID
- 2017-A0392-51
- Acronym
- OnaDEP
- Status last verified
- Oct 2021
- First submitted
- 26 Mar 2018
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40226647
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites at Three Months.
- ClinicalTrials.gov ID
- NCT03484754
- Acronym / sponsor ID
- OnaDEP / 2017-A0392-51
- Conditions
- Major Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| corrugator | Experimental | Biological: botulinum toxinsingle injection of 10 Units of botulinum toxina in the corrugator and procerus |
| orbicularis oculi | Active comparator | Biological: botulinum toxinsingle injection of 10 Units of botulinum toxina in the lateral muscle orbicularis oculi (involved in crow's feet wrinkles) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxininjection of botulinum toxina in two different facial sites | Biological | corrugator, orbicularis oculi |
Primary outcome
proportion of patients with improvement of depressive symptoms based on the evolution of the MADRS scale
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Derived from this study: PubMed 40226647Ceolato-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Charles, MD principal investigator
Centre Hospitalier Esquirol
Danièle Ranoux, MD, PhD study director
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing botulinum toxin in people with Major Depression, run by Centre Hospitalier Esquirol at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with improvement of depressive symptoms based on the evolution of the MADRS scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03484754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.