SchizophreniaSURECTNCT03542903
ECT in Ultra-resistant Schizophrenia
A study testing Electroconvulsive therapy in people with Schizophrenia and Electroconvulsive Therapy, run by Centre Hospitalier du Rouvray at 10 sites in France.
Trial summary
The effects of the ECT in schizophrenia ultra-resistant were studied in short times (4-6 months in most studies with follow-up). The literature identified a high relapse rate of 32% in the weeks to months after ECT discontinuation. The use of the ECT in the prevention of the relapse is partially known. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Electroconvulsive Therapy
- What is being tested?
- Electroconvulsive therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 10 sitesFrance
- Study dates
- 4 Jul 2018to 4 Oct 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with URS: patients who continue to experience persistent positive psychotic symptoms: item score of 4 (moderate) on at least two of four positive symptoms on the BPRS (grandiosity, suspiciousness, hallucinations and unusual thoughts), current presence of at least moderately severe illness on the total BPRS-18 (45) and a score of 4 (moderate) on the CGI-S, despite a period of clozapine therapy of at least 6 weeks with a plasma concentration of 350 ng/ml and at least two unsuccessful previous treatment trials with conventional or atypical antipsychotic drugs from two distinct families at a dose 600 mg of chlorpromazine equivalents.
- Age: from 18 to 55
- Patients with stable treatments for at least 8 weeks (antipsychotics, mood stabilizers and antidepressants).
- Participants who gave their informed, written consents and agreement of their guardian for the patients under guardianship
- Patients deprived of liberty if they gave their informed, written consents
Who cannot join
- Current affective episode according to DSM-5 criteria;
- ECT within (the last) 6 months;
- Unstable epilepsy ; severe neurological or systemic disorder that could significantly affect cognition, behavior, or mental status (other than late dyskinesia or neuroleptic-induced parkinsonism);
- Severe substance use disorders (other than nicotine or caffeine) according to DSM-5 criteria.
- Concomitant use of antiepileptics and benzodiazepines apart from lamotrigine
- Women of childbearing age with no adequate contraception, pregnant or lactating women;
Show all 9Show fewer
- Patients having contraindications to etomidate or any of its excipients;
- Patients having contraindications to neuromuscular blocking agents;
- Patients participating or having participated in an interventional clinical trial within 30 days prior to the inclusion visit;
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites, 10 recruiting
- Not yet recruiting
Centre Hospitalier Charles Perrens
Bordeaux, 33076
Clelia Quiles, Md,PhD
Clelia Quiles, MD,PhD
- Not yet recruiting
Centre Hospitalier de Cadillac
Cadillac, 33410
Patrick Le Bihan, MD
Patrick Le Bihan, MD
- Recruiting
CHU de Caen
Caen, 14033
Pierrick Lebain, MD
Pierrick Lebain, MD
- Recruiting
Clermont-Ferrand Hospital
Clermont-Ferrand
Pierre-Michel Llorca, MD, PhD
- Recruiting
Montpellier University Hospital
Montpellier
Jerôme Attal, MD
- Recruiting
CHU de Nantes
Nantes, 44000
Anne Sauvaget, MD,PhD
Anne Sauvaget, MD,PhD
- Not yet recruiting
EPS Ville Evrard
Neuilly-sur-Marne
Dominique Januel, MD, PhD
Noomane Bouaziz, MD
- Recruiting
Centre Hospitalier Saint Anne
Paris, 75014
Marie-Odile Krebs, MD,PhD
Marie-Odile Krebs, MD,PhD
- Recruiting
Centre Hospitalier Henri Laborit
Poitiers, 86021
Nemat Jaafari, MD,PhD
Nemat Jaafari, Md,PhD
- Recruiting
CHU de Toulouse
Toulouse, 31059
Christophe Arbus, MD
Christophe Arbus, MD
About this study
Official title: Clinical Trial Comparing Two Electroconvulsive Therapy (ECT) Application Schemas in Ultra-resistant Schizophrenia
The effects of the ECT in schizophrenia ultra-resistant were studied in short times (4-6 months in most studies with follow-up). The literature identified a high relapse rate of 32% in the weeks to months after ECT discontinuation. The use of the ECT in the prevention of the relapse is partially known. In an empirical way, experts recommend protocols of prevention of the relapse going from 6 to 12 months. Nevertheless, the profit of a long cure (12 months) compared with a short cure (6 months) was never determined. Therefore, the investigators decided to lead a prospective randomized controlled study in order to compare the response rates between the two strategies of clozapine and ECT combinations applied to URS patients. The treatment consisted either in a short therapy of six months or a longer course of therapy of twelve months. To the investigators' knowledge, it is the first study which compares two ECT strategies (both the short duration and the longer one) for the treatment of URS patients.
- Conditions
- Schizophrenia, Electroconvulsive Therapy
- Being tested
- Electroconvulsive therapy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapyDevice
Electroconvulsive therapy is administered through electrodes positioned bilaterally (for quicker efficacy) on the frontotemporal region.
The stimulation dose is determined by titration method, during the first ECT session.
The dose for therapeutic stimulation will be twice the seizure threshold. This dose may be increased as the crisis does not meet the effectiveness criteria, as is recommended.
For patients undergoing ECT, an intravenous injection of etomidate (between 0.1 and 0.7 mg/kg) and suxamethonium chloride (0.8 and 1.2 mg/kg) is performed. The required doses are adapted according to each patient by the anaesthetist and they are documented in the patients' files. A mixture of etomidate and propofol can be used in second-line or just propofol in third-line (no more than 2mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| Short ECT arm | Active comparator | In the short arm, bitemporal ECT is administered twice a week during the first 6 weeks. Afterwards, it is administered once a week during 4 weeks. After that, the patients will have one ECT every 3 weeks during 6 weeks. Lastly, patients will receive one ECT each month during 2 months. Receives: Device: Electroconvulsive therapy |
| Long ECT arm | Active comparator | In the long arm, bitemporal ECT is administered twice a week during the first 12 weeks. Afterwards, it is administered once a week during 8 weeks. After that, the patients will have one ECT every 3 weeks during 12 weeks. Lastly, patients will receive one ECT each month during 4 months. Receives: Device: Electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate (a 30% decrease in the Positive and Negative Syndrome Scale (PANSS)) at 15th month
The response rate (a 30% decrease in the PANSS, ranging from 30, the minimum, to 210, the most severe score) at 15th month
Measured: three months after the end of the treatment (i.e. 9 and 15 months)
Secondary outcomes (13)
The response rate (a 30% decrease in the Brief Psychiatric Rating Scale (BPRS))
The response rate (a 30% decrease in the BPRS, ranging from 18, the minimum, to 126, the most severe score) at 15th month.
Measured: three months after the end of the treatment (i.e. 9 and 15 months)
The response rate (a 30% decrease in the BPRS) at different times of the study
The response rate (a 30 % decrease in the BPRS) at 2, 4, 6 and 12 months.
Measured: 2, 4, 6 and 12 months
Response rate (a 30% decrease in the PANSS) at different times of the study
The response rate (a 30 % decrease in the PANSS) at 2, 4, 6 and 12 months.
Measured: 2, 4, 6 and 12 months
Neuropsychological assessment- MMSE
The scores and variations of the Mini Mental Status Examination (MMSE) at -1, 6 and 15 months.
Measured: -1, 6 and 15 months
Neuropsychological assessment- SSTICS
The scores and variations of the Subjective Scale To Investigate Cognition In Schizophrenia (SSTICS, scores ranging from 0 to 84, the most severe score) at -1, 6 and 15 months.
Measured: -1, 6 and 15 months
Neuropsychological assessment- Grober and Buschke test
The scores and variations of the test of Grober and Buschke at -1, 6 and 15 months.
Measured: -1, 6 and 15 months
Neuropsychological assessment- test of doors
The scores and variations of the test of doors at -1, 6 and 15 months.
Measured: -1, 6 and 15 months
Neuropsychological assessment- test of d2
The scores and variations of the test of d2 at -1, 6 and 15 months.
Measured: -1, 6 and 15 months
Neuropsychological assessment - "figure de Rey" test
the scores ans variations of the test of " figure de Rey" at -1, 6 and 15 months.
Measured: -1, 6 and 15 months
Other clinical assessment- HAMD-21
The scores and variations of the Hamilton Rating Scale-21 items (HAMD-21, scores ranging from 0 to 64, the most severe score) at day 1 and 2, 4, 6, 9, 12 and 15 months.
Measured: day 1 and 2, 4, 6, 9, 12 and 15 months
Other clinical assessment-YMRS
The scores and variations of the Young Mania Rating Scale (YMRS, scores ranging from 0 to 60, the most severe score) at day 1 and 2, 4, 6, 9, 12 and 15 months.
Measured: day 1 and 2, 4, 6, 9, 12 and 15 months
Other clinical assessment-GAF
The scores and variations of the Global Assessment Functioning (GAF, scores ranging from 0 to 100, the best score) at day 1 and 2, 4, 6, 9, 12 and 15 months.
Measured: day 1 and 2, 4, 6, 9, 12 and 15 months
Other clinical assessment-MOAS
The scores and variations of the Modified Overt Aggression Scale (MOAS, scores ranging from 0 to 100, the most severe score) at day 1 and 2, 4, 6, 9, 12 and 15 months.
Measured: day 1 and 2, 4, 6, 9, 12 and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start4 Jul 2018
- Primary completion4 Oct 2023 (estimated)
- Study completion4 Oct 2023 (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 SchizophreniaStudies 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
- A multicentric, prospective, random-assignment study incorporating both non-blinded treatment and blinded assessment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier du Rouvray
- Sponsor type
- Other government
- Collaborators
- University Hospital, Rouen, University Hospital, Bordeaux, Nantes University Hospital, University Hospital, Toulouse, University Hospital, Caen, Centre Hospitalier Henri Laborit, Centre Hospitalier St Anne, Centre Hospitalier de Cadillac, Hôpital Louis Mourier, University Hospital, Montpellier, University Hospital, Clermont-Ferrand, Centre hospitalier de Ville-Evrard, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542903
- Sponsor's protocol ID
- 2017-A02657-46
- Acronym
- SURECT
- Status last verified
- Sep 2020
- First submitted
- 11 Apr 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moulier V, Krir MW, Dalmont M; SURECT Group; Guillin O, Rotharmel M. A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study). Trials. 2021 Apr 15;22(1):284. doi: 10.1186/s13063-021-05227-3.
PubMed 33858488
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Comparing Two Electroconvulsive Therapy (ECT) Application Schemas in Ultra-resistant Schizophrenia
- ClinicalTrials.gov ID
- NCT03542903
- Acronym / sponsor ID
- SURECT / 2017-A02657-46
- Conditions
- Schizophrenia, Electroconvulsive Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Centre Hospitalier du RouvrayOther government
- Collaborators
- University Hospital, Rouen, University Hospital, Bordeaux, Nantes University Hospital, University Hospital, Toulouse, University Hospital, Caen, Centre Hospitalier Henri Laborit, Centre Hospitalier St Anne, Centre Hospitalier de Cadillac, Hôpital Louis Mourier, University Hospital, Montpellier, University Hospital, Clermont-Ferrand, Centre hospitalier de Ville-Evrard, France
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 4 Oct 2023 (estimated)
- Study completion
- 4 Oct 2023 (estimated)
- First posted
- 31 May 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 effects of the ECT in schizophrenia ultra-resistant were studied in short times (4-6 months in most studies with follow-up). The literature identified a high relapse rate of 32% in the weeks to months after ECT discontinuation. The use of the ECT in the prevention of the relapse is partially known. In an empirical way, experts recommend protocols of prevention of the relapse going from 6 to 12 months. Nevertheless, the profit of a long cure (12 months) compared with a short cure (6 months) was never determined. Therefore, the investigators decided to lead a prospective randomized controlled study in order to compare the response rates between the two strategies of clozapine and ECT combinations applied to URS patients. The treatment consisted either in a short therapy of six months or a longer course of therapy of twelve months. To the investigators' knowledge, it is the first study which compares two ECT strategies (both the short duration and the longer one) for the treatment of URS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A multicentric, prospective, random-assignment study incorporating both non-blinded treatment and blinded assessment
| Arm | Type | Receives |
|---|---|---|
| Short ECT arm | Active comparator | Device: Electroconvulsive therapyIn the short arm, bitemporal ECT is administered twice a week during the first 6 weeks. Afterwards, it is administered once a week during 4 weeks. After that, the patients will have one ECT every 3 weeks during 6 weeks. Lastly, patients will receive one ECT each month during 2 months. |
| Long ECT arm | Active comparator | Device: Electroconvulsive therapyIn the long arm, bitemporal ECT is administered twice a week during the first 12 weeks. Afterwards, it is administered once a week during 8 weeks. After that, the patients will have one ECT every 3 weeks during 12 weeks. Lastly, patients will receive one ECT each month during 4 months. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with URS: patients who continue to experience persistent positive psychotic symptoms: item score of 4 (moderate) on at least two of four positive symptoms on the BPRS (grandiosity, suspiciousness, hallucinations and unusual thoughts), current presence of at least moderately severe illness on the total BPRS-18 (45) and a score of 4 (moderate) on the CGI-S, despite a period of clozapine therapy of at least 6 weeks with a plasma concentration of 350 ng/ml and at least two unsuccessful previous treatment trials with conventional or atypical antipsychotic drugs from two distinct families at a dose 600 mg of chlorpromazine equivalents.
- Age: from 18 to 55
- Patients with stable treatments for at least 8 weeks (antipsychotics, mood stabilizers and antidepressants).
- Participants who gave their informed, written consents and agreement of their guardian for the patients under guardianship
- Patients deprived of liberty if they gave their informed, written consents
Key exclusion criteria (9 listed)
- Current affective episode according to DSM-5 criteria;
- ECT within (the last) 6 months;
- Unstable epilepsy ; severe neurological or systemic disorder that could significantly affect cognition, behavior, or mental status (other than late dyskinesia or neuroleptic-induced parkinsonism);
- Severe substance use disorders (other than nicotine or caffeine) according to DSM-5 criteria.
- Concomitant use of antiepileptics and benzodiazepines apart from lamotrigine
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 |
|---|---|---|
| Electroconvulsive therapyElectroconvulsive therapy is administered through electrodes positioned bilaterally (for quicker efficacy) on the frontotemporal region. The stimulation dose is determined by titration method, during the first ECT session. The dose for therapeutic stimulation will be twice the seizure threshold. This dose may be increased as the crisis does not meet the effectiveness criteria, as is recommended. For patients undergoing ECT, an intravenous injection of etomidate (between 0.1 and 0.7 mg/kg) and suxamethonium chloride (0.8 and 1.2 mg/kg) is performed. The required doses are adapted according to each patient by the anaesthetist and they are documented in the patients' files. A mixture of etomidate and propofol can be used in second-line or just propofol in third-line (no more than 2mg/kg). | Device | Long ECT arm, Short ECT arm |
Primary outcome
The response rate (a 30% decrease in the Positive and Negative Syndrome Scale (PANSS)) at 15th month
Time frame: three months after the end of the treatment (i.e. 9 and 15 months)
The response rate (a 30% decrease in the PANSS, ranging from 30, the minimum, to 210, the most severe score) at 15th month
13 secondary outcomes
The response rate (a 30% decrease in the Brief Psychiatric Rating Scale (BPRS))
Time frame: three months after the end of the treatment (i.e. 9 and 15 months)
The response rate (a 30% decrease in the BPRS) at different times of the study
Time frame: 2, 4, 6 and 12 months
Response rate (a 30% decrease in the PANSS) at different times of the study
Time frame: 2, 4, 6 and 12 months
Neuropsychological assessment- MMSE
Time frame: -1, 6 and 15 months
Neuropsychological assessment- SSTICS
Time frame: -1, 6 and 15 months
Neuropsychological assessment- Grober and Buschke test
Time frame: -1, 6 and 15 months
Neuropsychological assessment- test of doors
Time frame: -1, 6 and 15 months
Neuropsychological assessment- test of d2
Time frame: -1, 6 and 15 months
Neuropsychological assessment - "figure de Rey" test
Time frame: -1, 6 and 15 months
Other clinical assessment- HAMD-21
Time frame: day 1 and 2, 4, 6, 9, 12 and 15 months
Other clinical assessment-YMRS
Time frame: day 1 and 2, 4, 6, 9, 12 and 15 months
Other clinical assessment-GAF
Time frame: day 1 and 2, 4, 6, 9, 12 and 15 months
Other clinical assessment-MOAS
Time frame: day 1 and 2, 4, 6, 9, 12 and 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 33858488Moulier V, Krir MW, Dalmont M; SURECT Group; Guillin O, Rotharmel M. A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study). Trials. 2021 Apr 15;22(1):284. doi: 10.1186/s13063-021-05227-3.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroconvulsive therapy in people with Schizophrenia and Electroconvulsive Therapy, run by Centre Hospitalier du Rouvray at 10 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 5 inclusion and 9 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maud Rothärmel, MD (0033232956825, maud.rotharmel@ch-lerouvray.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rate (a 30% decrease in the Positive and Negative Syndrome Scale (PANSS)) at 15th month (time frame: three months after the end of the treatment (i.e. 9 and 15 months)). 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 NCT03542903, 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 16 Sep 2020.