Refractory SchizophreniaPhase 4SSURECTNCT02049021
Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia
A Phase 4 study testing MECTA SPECTRUM 5000Q ECT in people with Refractory Schizophrenia and Super Refractory Schizophrenia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Introduction: In spite of recent advances in schizophrenia treatment, 30% of patients still do not respond properly to antipsychotic therapy. These patients are considered treatment-resistant or refractory, and the best choice for them is clozapine. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Refractory Schizophrenia, Super Refractory Schizophrenia
- What is being tested?
- MECTA SPECTRUM 5000Q ECT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Jan 2014
- Phase
- Phase 4
- 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
- Clinical diagnosis of schizophrenia or schizoaffective disorder (DSM-IV-TR);
- Ages between 18 and 55 years old, both genders;
- Must be using adequate contraception if a fertile woman;
- Must be on clozapine treatment for at least 6 months, with or without augmenting strategies;
- Must be clozapine-resistent (super-refractory patient), defined by a CGI-severity ≥ 4, PANSS total score ≥ 60 and at least 4 items of the positive subscale ≥ 4 at baseline.
Who cannot join
- Clinical somatic disease not stabilized in the three months preceding the study;
- Other Axis I disorders (DSM-IV-TR);
- Laboratory tests with significantly abnormal values that persist for more than two weeks;
- Lack of permanent residence during the study period;
- History of poor treatment adherence.
- History of ECT use in the past six months that precede the start of the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Institute of Psychiatry - Clinics Hospital - University of Sao Paulo
São Paulo, São Paulo, 05403010
Helio Elkis, Md PhD, +55-11-2661-7322
Debora Melzer, MD, +551126616525, deboramelzer@yahoo.com.br
About this study
Official title: Pilot Double Blind, Placebo Controlled and Randomized Study to Assess Electroconvulsive Therapy Efficacy as Augmenting Strategy to Clozapine in Super-refractory Schizophrenia
Introduction: In spite of recent advances in schizophrenia treatment, 30% of patients still do not respond properly to antipsychotic therapy. These patients are considered treatment-resistant or refractory, and the best choice for them is clozapine. However, even supported by the literature as the best known antipsychotic in terms of efficacy and rates of response, a considerable number of patients will still not respond to this treatment, remaining symptomatic and dysfunctional. These patients are classified as super-refractory (clozapine-resistent). In these cases, augmenting strategies are necessary, and some have been in use: typical and atypical antipsychotics, mood stabilizers, antidepressants and electroconvulsive therapy (ECT). Some studies have favored ECT, but no definitive conclusion has been drawn.
Objective: Test the electroconvulsive therapy efficacy and safety as augmenting strategy to clozapine-resistant patients, as compared to placebo (sham ECT).
Methods: This is a pilot double blind, placebo controlled and randomized study to assess electroconvulsive therapy efficacy as augmenting strategy to clozapine in super-refractory schizophrenia. The ECT treatment will be delivered with either a MECTA SPECTRUM 5000Q or 4000Q device, and the procedure is under general anesthesia and monitorization, after informed consent. The Hospital will follow national protocols and regulations on ECT. Sham ECT consists in habitual patient preparation and sedation, without stimulation. Patients that fit inclusion criteria will have their clozapine blood levels dosed and undergo structured assessments at baseline, after 6 treatments and at the end of the cycle of 12 ECT sessions (thrice a week protocol). The assessments will be based on CGI (Clinical Global Impression) and PANSS (Positive and Negative Syndrome Scale) scales. All medication will be maintained, except lithium carbonate.
- Being tested
- MECTA SPECTRUM 5000Q ECT, Sham ECT
- Keywords
- schizophrenia, electroconvulsive therapy, refractory Schizophrenia, super refractory schizophrenia, clozapine
- Medical subject headings
- Schizophrenia, Treatment-Resistant, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MECTA SPECTRUM 5000Q ECTDevice
Also called ECT, Electrochock, electroconvulsive therapy device
Sham ECTProcedure or surgery
Sedation using propofol or etomidate and usual ECT preparation (no stimulation)
| Study group | Role | What they receive |
|---|---|---|
| Electroconvulsive Therapy | Experimental | Patients in use of clozapine randomized to receive ECT treatment Receives: Device: MECTA SPECTRUM 5000Q ECT |
| SHAM ECT | Sham comparator | Patients receiving clozapine randomized to sham ECT (placebo) Receives: Procedure: Sham ECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS change from baseline
Structured assessments will be done at baseline, and at the end of the cycle of 12 ECT sessions (thrice a week protocol). The assessments will be based on PANSS (Positive and Negative Syndrome Scale). Changes from Baseline on this scale will be documented after a 4 weeks period.
Measured: 4 weeks
PANSS change from baseline
Structured assessments will be done at baseline, and at the end of the cycle of 6 ECT sessions (thrice a week protocol). The assessments will be based on PANSS (Positive and Negative Syndrome Scale). Changes from Baseline on this scale will be documented after a 2 week period.
Measured: 2 weeks
Secondary outcomes (2)
CGI change from baseline
Clinical Global Impression will be assessed as well, along with PANSS scale, and changes compared to baseline.
Measured: 4 weeks
CGI change from baseline
Clinical Global Impression will be assessed as well, along with PANSS scale, and changes compared to baseline.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startFeb 2010
- Primary completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Refractory 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helio Elkis, University of Sao Paulo
- Investigators
- Hélio Elkis, MD PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049021
- Sponsor's protocol ID
- ECT Schizo
- Acronym
- SSURECT
- Status last verified
- Jan 2014
- First submitted
- 15 Jan 2014
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elkis H. Treatment-resistant schizophrenia. Psychiatr Clin North Am. 2007 Sep;30(3):511-33. doi: 10.1016/j.psc.2007.04.001.
PubMed 17720034Havaki-Kontaxaki BJ, Ferentinos PP, Kontaxakis VP, Paplos KG, Soldatos CR. Concurrent administration of clozapine and electroconvulsive therapy in clozapine-resistant schizophrenia. Clin Neuropharmacol. 2006 Jan-Feb;29(1):52-6. doi: 10.1097/00002826-200601000-00012.
PubMed 16518135Kho KH, Blansjaar BA, de Vries S, Babuskova D, Zwinderman AH, Linszen DH. Electroconvulsive therapy for the treatment of clozapine nonresponders suffering from schizophrenia--an open label study. Eur Arch Psychiatry Clin Neurosci. 2004 Dec;254(6):372-9. doi: 10.1007/s00406-004-0517-y. Epub 2004 Nov 12.
PubMed 15538604Lehman AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, Kreyenbuhl J; American Psychiatric Association; Steering Committee on Practice Guidelines. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004 Feb;161(2 Suppl):1-56. No abstract available.
PubMed 15000267Miller A, Hall CS, Buchanan RW, Buckley PF, Chiles JA, Conley RR, Crismon ML, Ereshefsky L, Essock SM, Finnerty M, Marder SR, Miller DD, McEvoy JP, Rush AJ, Saeed SA, Schooler NR, Shon SP, Stroup S, Tarin-Godoy B. The Texas Medication Algorithm Project antipsychotic algorithm for schizophrenia: 2003 update. J Clin Psychiatry. 2004 Apr;65(4):500-8. doi: 10.4088/jcp.v65n0408.
PubMed 15119912Tang WK, Ungvari GS. Efficacy of electroconvulsive therapy in treatment-resistant schizophrenia: a prospective open trial. Prog Neuropsychopharmacol Biol Psychiatry. 2003 May;27(3):373-9. doi: 10.1016/S0278-5846(02)00354-8.
PubMed 12691772Tharyan P, Adams CE. Electroconvulsive therapy for schizophrenia. Cochrane Database Syst Rev. 2002;(2):CD000076. doi: 10.1002/14651858.CD000076.
PubMed 12076380
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Double Blind, Placebo Controlled and Randomized Study to Assess Electroconvulsive Therapy Efficacy as Augmenting Strategy to Clozapine in Super-refractory Schizophrenia
- ClinicalTrials.gov ID
- NCT02049021
- Acronym / sponsor ID
- SSURECT / ECT Schizo
- Keywords
- schizophrenia, electroconvulsive therapy, refractory Schizophrenia, super refractory schizophrenia, clozapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2014 (actual)
- First posted
- 29 Jan 2014 (estimated)
- 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.
Introduction: In spite of recent advances in schizophrenia treatment, 30% of patients still do not respond properly to antipsychotic therapy. These patients are considered treatment-resistant or refractory, and the best choice for them is clozapine. However, even supported by the literature as the best known antipsychotic in terms of efficacy and rates of response, a considerable number of patients will still not respond to this treatment, remaining symptomatic and dysfunctional. These patients are classified as super-refractory (clozapine-resistent). In these cases, augmenting strategies are necessary, and some have been in use: typical and atypical antipsychotics, mood stabilizers, antidepressants and electroconvulsive therapy (ECT). Some studies have favored ECT, but no definitive conclusion has been drawn.
Objective: Test the electroconvulsive therapy efficacy and safety as augmenting strategy to clozapine-resistant patients, as compared to placebo (sham ECT).
Methods: This is a pilot double blind, placebo controlled and randomized study to assess electroconvulsive therapy efficacy as augmenting strategy to clozapine in super-refractory schizophrenia. The ECT treatment will be delivered with either a MECTA SPECTRUM 5000Q or 4000Q device, and the procedure is under general anesthesia and monitorization, after informed consent. The Hospital will follow national protocols and regulations on ECT. Sham ECT consists in habitual patient preparation and sedation, without stimulation. Patients that fit inclusion criteria will have their clozapine blood levels dosed and undergo structured assessments at baseline, after 6 treatments and at the end of the cycle of 12 ECT sessions (thrice a week protocol). The assessments will be based on CGI (Clinical Global Impression) and PANSS (Positive and Negative Syndrome Scale) scales. All medication will be maintained, except lithium carbonate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroconvulsive Therapy | Experimental | Device: MECTA SPECTRUM 5000Q ECTPatients in use of clozapine randomized to receive ECT treatment |
| SHAM ECT | Sham comparator | Procedure: Sham ECTPatients receiving clozapine randomized to sham ECT (placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of schizophrenia or schizoaffective disorder (DSM-IV-TR);
- Ages between 18 and 55 years old, both genders;
- Must be using adequate contraception if a fertile woman;
- Must be on clozapine treatment for at least 6 months, with or without augmenting strategies;
- Must be clozapine-resistent (super-refractory patient), defined by a CGI-severity ≥ 4, PANSS total score ≥ 60 and at least 4 items of the positive subscale ≥ 4 at baseline.
Key exclusion criteria (6 listed)
- Clinical somatic disease not stabilized in the three months preceding the study;
- Other Axis I disorders (DSM-IV-TR);
- Laboratory tests with significantly abnormal values that persist for more than two weeks;
- Lack of permanent residence during the study period;
- History of poor treatment adherence.
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 |
|---|---|---|
| MECTA SPECTRUM 5000Q ECTAlso: ECT, Electrochock, electroconvulsive therapy device | Device | Electroconvulsive Therapy |
| Sham ECTSedation using propofol or etomidate and usual ECT preparation (no stimulation) | Procedure or surgery | SHAM ECT |
Primary outcome
PANSS change from baseline
Time frame: 4 weeks
Structured assessments will be done at baseline, and at the end of the cycle of 12 ECT sessions (thrice a week protocol). The assessments will be based on PANSS (Positive and Negative Syndrome Scale). Changes from Baseline on this scale will be documented after a 4 weeks period.
PANSS change from baseline
Time frame: 2 weeks
Structured assessments will be done at baseline, and at the end of the cycle of 6 ECT sessions (thrice a week protocol). The assessments will be based on PANSS (Positive and Negative Syndrome Scale). Changes from Baseline on this scale will be documented after a 2 week period.
2 secondary outcomes
CGI change from baseline
Time frame: 4 weeks
CGI change from baseline
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Background: PubMed 17720034Elkis H. Treatment-resistant schizophrenia. Psychiatr Clin North Am. 2007 Sep;30(3):511-33. doi: 10.1016/j.psc.2007.04.001.
- Background: PubMed 16518135Havaki-Kontaxaki BJ, Ferentinos PP, Kontaxakis VP, Paplos KG, Soldatos CR. Concurrent administration of clozapine and electroconvulsive therapy in clozapine-resistant schizophrenia. Clin Neuropharmacol. 2006 Jan-Feb;29(1):52-6. doi: 10.1097/00002826-200601000-00012.
- Background: PubMed 15538604Kho KH, Blansjaar BA, de Vries S, Babuskova D, Zwinderman AH, Linszen DH. Electroconvulsive therapy for the treatment of clozapine nonresponders suffering from schizophrenia--an open label study. Eur Arch Psychiatry Clin Neurosci. 2004 Dec;254(6):372-9. doi: 10.1007/s00406-004-0517-y. Epub 2004 Nov 12.
- Background: PubMed 15000267Lehman AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, Kreyenbuhl J; American Psychiatric Association; Steering Committee on Practice Guidelines. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004 Feb;161(2 Suppl):1-56. No abstract available.
- Background: PubMed 15119912Miller A, Hall CS, Buchanan RW, Buckley PF, Chiles JA, Conley RR, Crismon ML, Ereshefsky L, Essock SM, Finnerty M, Marder SR, Miller DD, McEvoy JP, Rush AJ, Saeed SA, Schooler NR, Shon SP, Stroup S, Tarin-Godoy B. The Texas Medication Algorithm Project antipsychotic algorithm for schizophrenia: 2003 update. J Clin Psychiatry. 2004 Apr;65(4):500-8. doi: 10.4088/jcp.v65n0408.
- Background: PubMed 12691772Tang WK, Ungvari GS. Efficacy of electroconvulsive therapy in treatment-resistant schizophrenia: a prospective open trial. Prog Neuropsychopharmacol Biol Psychiatry. 2003 May;27(3):373-9. doi: 10.1016/S0278-5846(02)00354-8.
- Background: PubMed 12076380Tharyan P, Adams CE. Electroconvulsive therapy for schizophrenia. Cochrane Database Syst Rev. 2002;(2):CD000076. doi: 10.1002/14651858.CD000076.
- Institute of Psychiatry - University of Sao PauloLink provided by the sponsor.
- Department of Psychiatry - University of Sao Paulo Medical SchoolLink provided by the sponsor.
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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.
Hélio Elkis, MD PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MECTA SPECTRUM 5000Q ECT in people with Refractory Schizophrenia and Super Refractory Schizophrenia, run by University of Sao Paulo at 1 site in Brazil.
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 6 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 29 Jan 2014. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Helio Elkis, MD,PhD (+55-1126617581, helkis@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS change from baseline (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT02049021, which also lists 7 linked publications.
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 29 Jan 2014.