Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial

NCT06456983 | Recruiting DMC

• 2 other identifiers: MECT-RESIST01KG2401
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 14

Brief 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. 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.

Conditions

Schizophrenia; Treatment Resistant Schizophrenia

Keywords

electroconvulsive therapy; ECT

Outcome Measures

Primary Outcomes (1)

• 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).

  28 weeks (duration of PHASE 2)

Secondary Outcomes (8)

• Number of relapse free subjects

  after 28 weeks, i.e. end of Phase 2

• BPRS

  after 28 weeks, i.e. end of Phase 2

• GAF:

  after 28 weeks, i.e. end of Phase 2

• SLSSWB:

  after 28 weeks, i.e. end of Phase 2

• PANSS:

  after 28 weeks, i.e. end of Phase 2

Other Outcomes (2)

• Cognition: MMSE:

  after 28 weeks, i.e. end of Phase 2

• THINC-it:

  after 28 weeks, i.e. end of Phase 2

Study Arms (2)

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.

Device: maintenance electroconvulsive therapy (mECT)

Interventions

maintenance electroconvulsive therapy (mECT) DEVICE

see Arms

maintenance electroconvulsive therapy (mECT) plus TAU

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (14)

Dept. of Psychiatry, RWTU Aachen

Aachen, Germany

NOT YET RECRUITING

Dept. of Psychiatry, University of Augsburg

Augsburg, Germany

NOT YET RECRUITING

Klinik für Psychiatrie, Göppingen

Göppingen, Germany

NOT YET RECRUITING

Departmet of Psychiatry, University Medical Center Göttingen

Göttingen, Germany

NOT YET RECRUITING

Dept. of Psychiatry, Hannover Medical School

Hanover, Germany

NOT YET RECRUITING

Universitätsklinikum Heidelberg, Klinik für Allgemeine Psychiatrie

Heidelberg, 69115, Germany

NOT YET RECRUITING

Zentrum für Psychische Gesundheit

Ingolstadt, Germany

NOT YET RECRUITING

Dept. of Psychiatry, University Mainz

Mainz, Germany

NOT YET RECRUITING

Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH)

Mannheim, 68159, Germany

RECRUITING

Dept. of Psychiatry, LMU München

München, Germany

NOT YET RECRUITING

Clinic for Psychiatry, Saarbrücken

Saarbrücken, Germany

NOT YET RECRUITING

Klinik für Psychiatrie, Siegen

Siegen, Germany

NOT YET RECRUITING

Dept. of Psychiatry, University Tübingen

Tübingen, Germany

NOT YET RECRUITING

Dept. of Psychiatry I, Wiesloch

Wiesloch, Germany

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 40420043 DERIVED

MeSH Terms

Conditions

Schizophrenia; Schizophrenia, Treatment-Resistant

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Alexander Sartorius, Prof

  Central Institute of Mental Health (CIMH), Mannheim, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Sartorius, Prof

CONTACT

+49-621-1703; alexander.sartorius@zi-mannheim.de

Christian R Wolf, Prof

CONTACT

+49-6221-56; Christian.Wolf@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: June 13, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (14)