SchizophreniaMECT-RESISTNCT06456983
Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
A study testing maintenance electroconvulsive therapy (mECT) in people with Schizophrenia and Treatment Resistant Schizophrenia, run by Central Institute of Mental Health, Mannheim at 14 sites in Germany.
Trial summary
Schizophrenia is one of the most severe and costliest mental disorders in terms of human suffering and societal expenditure. About 15-30% of patients do not respond to all known antipsychotics, including clozapine, the current gold-standard in these cases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia, Treatment Resistant Schizophrenia
- What is being tested?
- maintenance electroconvulsive therapy (mECT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 14 sitesGermany
- Study dates
- 14 Feb 2025to Jul 2028
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), BPRS total score > 45 and history of clozapine resistant schizophrenia (CRS), which will include treatment-resistant schizophrenia with clozapine intolerance or absolute contraindications for clozapine;
Who cannot join
- Diagnosis of DSM-5 major neurocognitive disorder ("dementia"), current severe substance-use disorder, affective disorders with psychotic symptoms or any personality disorder;
- Inability to read/write German
- Pregnancy or breast-feeding;
- General medical condition contraindicating ECT.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Germany14 sites, 14 recruiting
- Not yet recruiting
Dept. of Psychiatry, RWTU Aachen
Aachen
Thomas Frodl, tfrodl@ukaachen.de
Michael Grözinger, mgroezinger@ukaachen.de
- Not yet recruiting
Dept. of Psychiatry, University of Augsburg
Augsburg
Alkomiet Hasan, Prof., alkomiet.hasan@med.uni-augsburg.de
- Not yet recruiting
Klinik für Psychiatrie, Göppingen
Göppingen
Nenad Vasic, Prof., nenad.vasic@christophsbad.de
- Not yet recruiting
Departmet of Psychiatry, University Medical Center Göttingen
Göttingen
David Zilles-Wegner, david.zilles@med.uni-goettingen.de
- Not yet recruiting
Dept. of Psychiatry, Hannover Medical School
Hanover
Hannah Maier, Dr., Maier.Hannah@mh-hannover.de
Kai Kahl, Prof., kahl.kai@mh-hannover.de
- Not yet recruiting
Universitätsklinikum Heidelberg, Klinik für Allgemeine Psychiatrie
Heidelberg, 69115
Christian Wolf, Christian.Wolf@med.uni-heidelberg.de
- Not yet recruiting
Zentrum für Psychische Gesundheit
Ingolstadt
Thomas Pollmächer, Prof., Thomas.Pollmaecher@klinikum-ingolstadt.de
Steffen Birkmann, Dr., Steffen.Birkmann@klinikum-ingolstadt.de
- Not yet recruiting
Dept. of Psychiatry, University Mainz
Mainz
Klaus Lieb, Prof., Klaus.Lieb@unimedizin-mainz.de
Wolfgang Kelsch, Prof., Wolfgang.Kelsch@unimedizin-mainz.de
- Recruiting
Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH)
Mannheim, 68159
Alexander Sartorius, alexander.sartorius@zi-mannheim.de
- Not yet recruiting
Dept. of Psychiatry, LMU München
München
Oliver Pogarell, Prof., Oliver.Pogarell@med.uni-muenchen.de
- Not yet recruiting
Clinic for Psychiatry, Saarbrücken
Saarbrücken
Ulrich Seidl, PD, u.seidl@sb.shg-kliniken.de
- Not yet recruiting
Klinik für Psychiatrie, Siegen
Siegen
Heiko Ullrich, Dr., h.ullrich@klinikum-siegen.de
Peter Plum, Dr., P.Plum@klinikum-siegen.de
- Not yet recruiting
Dept. of Psychiatry, University Tübingen
Tübingen
Sarah Kayser, Prof., Sarah.Kayser@med.uni-tuebingen.de
Andreas Fallgatter, Prof., Andreas.Fallgatter@med.uni-tuebingen.de
- Not yet recruiting
Dept. of Psychiatry I, Wiesloch
Wiesloch
Markus Schwarz, Dr., Markus.Schwarz@PZN-Wiesloch.de
Jutta Kammerer-Ciernioch, Dr., jutta.kammerer@pzn-wiesloch.de
About this study
Schizophrenia is one of the most severe and costliest mental disorders in terms of human suffering and societal expenditure. About 15-30% of patients do not respond to all known antipsychotics, including clozapine, the current gold-standard in these cases. Hence, a recent Cochrane review stated that the quality of the existing studies is too poor to recommend any intervention in addition to clozapine and that new, randomized controlled trials independent from the pharmaceutical industry need to be performed to substantially improve patient care. Although electroconvulsive therapy (ECT) was initially used to treat schizophrenia, it is nowadays by far underused in the therapy of schizophrenia in many countries. ECT is well known to be highly effective in clozapine-treatment-resistant schizophrenia (CRS), and synergistic effects of clozapine and ECT have been demonstrated. However, relapse rates after successful courses of ECT are still very high, and evidence for maintenance ECT (mECT) in CRS is scarce at best. In a multi-center trial the investigators aim to examine the effectiveness of mECT in treatment-resistant patients with schizophrenia who improved after a course of routine ECT. If mECT will lead to a later timepoint of relapse and/or to a higher proportion of relapse-free patients compared to those undergoing treatment as usual, this trial would have an enormous impact on therapeutic strategies for "treatment-resistant" patients and would induce a profound change of current treatment guidelines, where ECT still ranks at the level of ultima ratio, despite accumulating evidence suggesting otherwise.
Read the detailed description
The scientific aim of the study is to conduct a multicenter, blinded, randomized and actively controlled trial to test the hypothesis that maintenance ECT (mECT) plus clozapine is superior to treatment with clozapine alone in CRS. Prior to the start of mECT (phase II), an acute ECT series (phase I) should have already led to a significant clinical improvement in CRS patients. The superiority of mECT will be proven by a longer time to relapse and secondarily by a lower number of patients with relapse compared to the control group.
Secondary objectives are to test the hypotheses that the global level of functioning and quality of life will increase, and that depression, overall symptoms of the schizophrenic syndrome, concomitant catatonic symptoms, stress and self-stigmatization will decrease compared to the control group. It is also expected that cognitive performance will not only not deteriorate, but will improve over the course of the mECT.
Once the positive ethics votes have been obtained, the first patients will be included at the individual centers following successful center initiation. In month 12 at the latest, the first patient should leave phase I after 6-9 weeks as a responder and will be randomized in phase II (clozapine versus clozapine plus mECT). At month 30 the last patient (total n = 84) should have been randomized as a responder from phase I and been included in phase II. At month 36 the last planned patient completes phase II of the study with his/her last study visit. Accordingly, he/she is the last patient to start the 12-month follow-up phase. In month 46 investigators will start final data evaluation and analysis. Investigators will complete the primary publication of the study this time point. After 4 years the last patient completes the 12-month follow-up phase. At study end final data evaluation and analysis regarding the primary endpoint of the follow-up phase takes place as well as the completion and submission of the primary publication of the follow-up.
- Conditions
- Schizophrenia, Treatment Resistant Schizophrenia
- Being tested
- maintenance electroconvulsive therapy (mECT)
- Keywords
- electroconvulsive therapy, ECT
- Medical subject headings
- Schizophrenia, Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintenance electroconvulsive therapy (mECT)Device
see Arms
| Study group | Role | What they receive |
|---|---|---|
| treatment as usual (TAU) | No intervention | Patients randomized to TAU only will continue on a stable drug regime for the next 28 weeks, but will not receive maintenance electroconvulsive therapy (mECT) |
| maintenance electroconvulsive therapy (mECT) plus TAU | Active comparator | All subjects will enter PHASE 1 and will receive a full course of routine ECT (maximum of 9 weeks and 18 total ECTs with 2-3 treatments per week) while being on stable antipsychotic medication. All ECT-responders (patients with improvement of 30% or more on Brief Psychiatric Rating Scale (BPRS) will enter PHASE 2 and will be randomly assigned to the active comparator (mECT plus treatment-as-usual, TAU) or the control intervention (TAU) which both last 28 weeks. Non-responders (patients without improvement of at least 30 % on BPRS scale) will not enter PHASE 2. Receives: Device: maintenance electroconvulsive therapy (mECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse
Time to relapse (relapse defined as BPRS 20 % higher than individual BPRS at start of PHASE 2 at any following study visit OR any unscheduled readmission due to a worsening of psychiatric symptoms OR any unscheduled visit with an BPRS 20 % higher than individual BPRS at start of PHASE 2 or death).
Measured: 28 weeks (duration of PHASE 2)
Secondary outcomes (8)
Number of relapse free subjects
Number of relapse free subjects at the end of PHASE 2
Measured: after 28 weeks, i.e. end of Phase 2
BPRS
BPRS: Brief Psychiatric Rating scale; higher is worse
Measured: after 28 weeks, i.e. end of Phase 2
GAF:
GAF: Global Assessment of Functioning; higher is better
Measured: after 28 weeks, i.e. end of Phase 2
SLSSWB:
SLSSWB: self-labeling, stigma stress and well-being (SLSSWB); descriptive subscales
Measured: after 28 weeks, i.e. end of Phase 2
PANSS:
PANSS: Positive and Negative Syndrome Scale; higher is worse
Measured: after 28 weeks, i.e. end of Phase 2
HAMD:
HAMD: Hamilton Depression scale; higher is worse
SSMIS-SF: Self-Stigma of Mental Illness Scale - Short Form; descriptive subscales
Measured: after 28 weeks, i.e. end of Phase 2
NCRS-dv:
NCRS-dv: Northoff catatonia rating scale (German version); higher is worse
Measured: after 28 weeks, i.e. end of Phase 2
Q-LES-Q-18:
Q-LES-Q-18: Quality of Life Enjoyment and Satisfaction Questionnaire (for patients with schizophrenia); higher is better
Measured: after 28 weeks, i.e. end of Phase 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start14 Feb 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (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
- This is a multi-center, observer-blind, randomized, and actively controlled parallel-group clinical trial to examine the effectiveness of mECT in clozapine resistant patients with schizophrenia (CRS) who improved after a full course of routine ECT.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Sartorius, Prof, Principal investigator, Central Institute of Mental Health (CIMH), Mannheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456983
- Sponsor's protocol ID
- MECT-RESIST
- Other IDs
- 01KG2401
- Acronym
- MECT-RESIST
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deicher A, Karl S, Otte ML, Knabbe J, Wendel B, Gose M, Wolf RC, Sartorius A. Study protocol of a German multi-center, observer-blind, randomized, and actively controlled parallel-group trial comparing maintenance electroconvulsive therapy to treatment as usual for relapse prevention in clozapine resistant schizophrenia. BMC Psychiatry. 2025 May 26;25(1):536. doi: 10.1186/s12888-025-06990-2.
PubMed 40420043
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
- ClinicalTrials.gov ID
- NCT06456983
- Acronym / sponsor ID
- MECT-RESIST / MECT-RESIST
- Conditions
- Schizophrenia, Treatment Resistant Schizophrenia
- Keywords
- electroconvulsive therapy, ECT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 13 Jun 2024 (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.
Schizophrenia is one of the most severe and costliest mental disorders in terms of human suffering and societal expenditure. About 15-30% of patients do not respond to all known antipsychotics, including clozapine, the current gold-standard in these cases. Hence, a recent Cochrane review stated that the quality of the existing studies is too poor to recommend any intervention in addition to clozapine and that new, randomized controlled trials independent from the pharmaceutical industry need to be performed to substantially improve patient care. Although electroconvulsive therapy (ECT) was initially used to treat schizophrenia, it is nowadays by far underused in the therapy of schizophrenia in many countries. ECT is well known to be highly effective in clozapine-treatment-resistant schizophrenia (CRS), and synergistic effects of clozapine and ECT have been demonstrated. However, relapse rates after successful courses of ECT are still very high, and evidence for maintenance ECT (mECT) in CRS is scarce at best. In a multi-center trial the investigators aim to examine the effectiveness of mECT in treatment-resistant patients with schizophrenia who improved after a course of routine ECT. If mECT will lead to a later timepoint of relapse and/or to a higher proportion of relapse-free patients compared to those undergoing treatment as usual, this trial would have an enormous impact on therapeutic strategies for "treatment-resistant" patients and would induce a profound change of current treatment guidelines, where ECT still ranks at the level of ultima ratio, despite accumulating evidence suggesting otherwise.
Detailed description
The scientific aim of the study is to conduct a multicenter, blinded, randomized and actively controlled trial to test the hypothesis that maintenance ECT (mECT) plus clozapine is superior to treatment with clozapine alone in CRS. Prior to the start of mECT (phase II), an acute ECT series (phase I) should have already led to a significant clinical improvement in CRS patients. The superiority of mECT will be proven by a longer time to relapse and secondarily by a lower number of patients with relapse compared to the control group.
Secondary objectives are to test the hypotheses that the global level of functioning and quality of life will increase, and that depression, overall symptoms of the schizophrenic syndrome, concomitant catatonic symptoms, stress and self-stigmatization will decrease compared to the control group. It is also expected that cognitive performance will not only not deteriorate, but will improve over the course of the mECT.
Once the positive ethics votes have been obtained, the first patients will be included at the individual centers following successful center initiation. In month 12 at the latest, the first patient should leave phase I after 6-9 weeks as a responder and will be randomized in phase II (clozapine versus clozapine plus mECT). At month 30 the last patient (total n = 84) should have been randomized as a responder from phase I and been included in phase II. At month 36 the last planned patient completes phase II of the study with his/her last study visit. Accordingly, he/she is the last patient to start the 12-month follow-up phase. In month 46 investigators will start final data evaluation and analysis. Investigators will complete the primary publication of the study this time point. After 4 years the last patient completes the 12-month follow-up phase. At study end final data evaluation and analysis regarding the primary endpoint of the follow-up phase takes place as well as the completion and submission of the primary publication of the follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multi-center, observer-blind, randomized, and actively controlled parallel-group clinical trial to examine the effectiveness of mECT in clozapine resistant patients with schizophrenia (CRS) who improved after a full course of routine ECT.
| Arm | Type | Receives |
|---|---|---|
| treatment as usual (TAU) | No intervention | –Patients randomized to TAU only will continue on a stable drug regime for the next 28 weeks, but will not receive maintenance electroconvulsive therapy (mECT) |
| maintenance electroconvulsive therapy (mECT) plus TAU | Active comparator | Device: maintenance electroconvulsive therapy (mECT)All subjects will enter PHASE 1 and will receive a full course of routine ECT (maximum of 9 weeks and 18 total ECTs with 2-3 treatments per week) while being on stable antipsychotic medication. All ECT-responders (patients with improvement of 30% or more on Brief Psychiatric Rating Scale (BPRS) will enter PHASE 2 and will be randomly assigned to the active comparator (mECT plus treatment-as-usual, TAU) or the control intervention (TAU) which both last 28 weeks. Non-responders (patients without improvement of at least 30 % on BPRS scale) will not enter PHASE 2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), BPRS total score > 45 and history of clozapine resistant schizophrenia (CRS), which will include treatment-resistant schizophrenia with clozapine intolerance or absolute contraindications for clozapine;
Key exclusion criteria (4 listed)
- Diagnosis of DSM-5 major neurocognitive disorder ("dementia"), current severe substance-use disorder, affective disorders with psychotic symptoms or any personality disorder;
- Inability to read/write German
- Pregnancy or breast-feeding;
- General medical condition contraindicating ECT.
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 |
|---|---|---|
| maintenance electroconvulsive therapy (mECT)see Arms | Device | maintenance electroconvulsive therapy (mECT) plus TAU |
Primary outcome
Time to relapse
Time frame: 28 weeks (duration of PHASE 2)
Time to relapse (relapse defined as BPRS 20 % higher than individual BPRS at start of PHASE 2 at any following study visit OR any unscheduled readmission due to a worsening of psychiatric symptoms OR any unscheduled visit with an BPRS 20 % higher than individual BPRS at start of PHASE 2 or death).
8 secondary outcomes
Number of relapse free subjects
Time frame: after 28 weeks, i.e. end of Phase 2
BPRS
Time frame: after 28 weeks, i.e. end of Phase 2
GAF:
Time frame: after 28 weeks, i.e. end of Phase 2
SLSSWB:
Time frame: after 28 weeks, i.e. end of Phase 2
PANSS:
Time frame: after 28 weeks, i.e. end of Phase 2
HAMD:
Time frame: after 28 weeks, i.e. end of Phase 2
NCRS-dv:
Time frame: after 28 weeks, i.e. end of Phase 2
Q-LES-Q-18:
Time frame: after 28 weeks, i.e. end of Phase 2
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 3 Feb 2026.
- Derived from this study: PubMed 40420043Deicher A, Karl S, Otte ML, Knabbe J, Wendel B, Gose M, Wolf RC, Sartorius A. Study protocol of a German multi-center, observer-blind, randomized, and actively controlled parallel-group trial comparing maintenance electroconvulsive therapy to treatment as usual for relapse prevention in clozapine resistant schizophrenia. BMC Psychiatry. 2025 May 26;25(1):536. doi: 10.1186/s12888-025-06990-2.
- 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.
Alexander Sartorius, Prof principal investigator
Central Institute of Mental Health (CIMH), Mannheim, Germany
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maintenance electroconvulsive therapy (mECT) in people with Schizophrenia and Treatment Resistant Schizophrenia, run by Central Institute of Mental Health, Mannheim at 14 sites in Germany.
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 4 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. 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?
Contact Alexander Sartorius, Prof (+49-621-1703 ext. 2913, alexander.sartorius@zi-mannheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to relapse (time frame: 28 weeks (duration of PHASE 2)). 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 NCT06456983, 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 3 Feb 2026.