Mental DisordersNCT04477434
French Observatory of ElectroConvulsive Therapy (ECT)
An observational study of Mental Disorders, run by Centre Hospitalier Henri Laborit at 30 sites in France.
Trial summary
Since the 30s, ECT has been a psychiatric treatment mainly used for drug-resistant depressive illnesses. Clinical studies have shown its therapeutic efficiency compared to standard treatments also in other psychiatric illnesses. Although efficient, ECTs also induce side effects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Disorders
- How many people
- 2,000 participants
- Where
- 30 sitesFrance
- Study dates
- 24 Apr 2018to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients receiving ECT as part of their medical treatment
Who may be able to join
- Patients consecutively referred for ECT.
Who cannot join
- Not specified
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
France30 sites, 30 recruiting
- Recruiting
CHU d'Angers : Site Larrey
Angers
Marine ROZET, MD, 0033 2 41 35 36 37
- Not yet recruiting
Clinique Mirambeau
Anglet
Christophe DAUDET, MD, 0033 5 59 52 33 00
- Recruiting
CHS de Montfavet
Avignon
Hosni EL OUAHCHI, MD, 0033 4 90 03 90 00
- Not yet recruiting
CH Cote Basque
Bayonne
Antoine OLIVEIRA, MD, 0033 5 59 44 35 35
- Not yet recruiting
Fondation bon sauveur
Bégard
Claire BERNARD, MD, 0033 2 96 45 20 10
- Not yet recruiting
Centre de crise Esquirol
Caen
Pierrick LEBAIN, MD
0033 2 31 06 50 62
- Not yet recruiting
CHU Gabriel Montpied
Clermont-Ferrand
Clémence MOREAU, MD
0033 4 73 75 07 50
- Not yet recruiting
CH La Chartreuse
Dijon
Jean-Claude GIROD, MD, 0033 3 80 42 48 48
- Recruiting
Clinique du domaine de Vontes
Esvres-sur-Indre
Isabelle RAMAGE, MD, 0033 2 47 34 15 15
- Not yet recruiting
Clinique de Pen-An-Dalar
Guipavas
Erwan LUVEN, MD, 0033 2 98 84 76 25
- Not yet recruiting
CUMP Océan Indien
La Réunion
Erick GOKALSING, MD, 00262 262 42 72 72
- Recruiting
CH Marius Lacroix
La Rochelle
Jean-Michel DURAND, MD, 0033 5 46 45 50 50, Marius-Lacroix@ch-larochelle.fr
- Recruiting
Césame
Les Ponts-de-Cé
Anne-Isabelle BOUYER, MD, 0033 2 41 80 79 08
- Not yet recruiting
CH de Mayenne
Mayenne
Mathilde SIX, MD, 0033 2 43 08 73 00
- Not yet recruiting
CHR Metz-Thionville
Metz
Pascal LE VAOU, MD, 0033 3 82 55 82 55
- Not yet recruiting
CH psy de la drôme Vivarais
Monteléger
Pierre COURVOISIER, MD, 0033 4 75 75 60 60
- Recruiting
CHS la Colombiere
Montpellier
Jérome ATTAL, MD, 0033 4 67 33 67 33
- Recruiting
CH Saint Roch
Nice
Laurent GUGENHEIM, MD, 0033 4 92 03 77 77
- Recruiting
CH Sainte Anne
Paris
Marion PLAZE, MD, 00 33 1 45 65 80 00
- Recruiting
CH Henri Laborit
Poitiers, 86000
Diane LEVY-CHAVAGNAT, MD, 00 335 49 44 58 56, halima.rakhila@ch-poitiers.fr
- Recruiting
CHI Redon-Carentoir
Redon
Sidi-Mohammed BENSENANE, MD, 0033 2 99 71 71 71
- Recruiting
CH Guillaume Regnier
Rennes
Dominique DRAPIER, MD, 0033 2 99 33 39 00
- Recruiting
CH du Rouvray
Rouen
Maud ROTHARMEL, MD, 0033 4 73 75 07 50
- Recruiting
Epsm du Morbihan
Saint-Avé
François-Alexis RICHARD, MD, 0033 2 97 54 49 49
- Recruiting
Clinique Villa du Parc
Saujon
Olivier DUBOIS, MD, 0033 5 46 23 50 00
- Not yet recruiting
CH Civil 1
Strasbourg
Atifa KORICHE, MD
0033 3 88 11 67 68
- Not yet recruiting
CH Nord Deux Sèvres
Thouars
Salima BRAIK, MD, 0033 5 49 68 49 68
- Not yet recruiting
CHITS CH Sainte Musse
Toulon
Jean-Luc BARTOLI, MD, 0033 4 94 14 50 00
- Not yet recruiting
CH Purpan
Toulouse
Antoine YRONDI, MD, 0033 5 61 77 22 33
- Recruiting
CPU de Tours
Tours
Maxime BONNIN, MD, 0033 2 34 37 89 47
About this study
Official title: Observatoire National d'ElectroConvulsivoThérapie (ECT)
Since the 30s, ECT has been a psychiatric treatment mainly used for drug-resistant depressive illnesses. Clinical studies have shown its therapeutic efficiency compared to standard treatments also in other psychiatric illnesses. Although efficient, ECTs also induce side effects. In France, there is currently no consensus on providing the suitest medical care. It is therefore important to review our nowadays health care models in order to maintain and improve the recommendations of the French National Agency for Accreditation and Evaluation in Health, the last of which date from 1997! Within this context, this project has the dual objective of (1) identifying ECT medical procedure in France and (2) developing research to evaluate and to improve the effectiveness of this treatment.
- Conditions
- Mental Disorders
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
ECT efficiency on patients
Measured: 2018-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start24 Apr 2018
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477434
- Sponsor's protocol ID
- 2035305v1
- Status last verified
- Aug 2024
- First submitted
- 15 Jul 2020
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatoire National d'ElectroConvulsivoThérapie (ECT)
- ClinicalTrials.gov ID
- NCT04477434
- Acronym / sponsor ID
- 2035305v1
- Conditions
- Mental Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Jul 2020 (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.
Since the 30s, ECT has been a psychiatric treatment mainly used for drug-resistant depressive illnesses. Clinical studies have shown its therapeutic efficiency compared to standard treatments also in other psychiatric illnesses. Although efficient, ECTs also induce side effects. In France, there is currently no consensus on providing the suitest medical care. It is therefore important to review our nowadays health care models in order to maintain and improve the recommendations of the French National Agency for Accreditation and Evaluation in Health, the last of which date from 1997! Within this context, this project has the dual objective of (1) identifying ECT medical procedure in France and (2) developing research to evaluate and to improve the effectiveness of this treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receiving ECT as part of their medical treatment
Key inclusion criteria (1 listed)
- Patients consecutively referred for ECT.
Key exclusion criteria (1 listed)
- Not specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ECT efficiency on patients
Time frame: 2018-2022
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorders, run by Centre Hospitalier Henri Laborit at 30 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECT efficiency on patients (time frame: 2018-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2024.