Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06456983

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

Led by Central Institute of Mental Health, Mannheim · Updated on 2026-02-03

140

Participants Needed

14

Research Sites

176 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Current diagnosis of schizophrenia according to DSM-5
  • BPRS total score greater than 45
  • History of clozapine-resistant schizophrenia, including intolerance or contraindications to clozapine
  • Age between 18 and 75 years
Not Eligible

You will not qualify if you...

  • Diagnosis of major neurocognitive disorder (dementia), severe substance-use disorder, affective disorders with psychotic symptoms, or any personality disorder
  • Inability to read or write German
  • Pregnancy or breastfeeding
  • Medical conditions that contraindicate electroconvulsive therapy (ECT)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 14 locations

1

Dept. of Psychiatry, RWTU Aachen

Aachen, Germany

Not Yet Recruiting

2

Dept. of Psychiatry, University of Augsburg

Augsburg, Germany

Not Yet Recruiting

3

Klinik für Psychiatrie, Göppingen

Göppingen, Germany

Not Yet Recruiting

4

Departmet of Psychiatry, University Medical Center Göttingen

Göttingen, Germany

Not Yet Recruiting

5

Dept. of Psychiatry, Hannover Medical School

Hanover, Germany

Not Yet Recruiting

6

Universitätsklinikum Heidelberg, Klinik für Allgemeine Psychiatrie

Heidelberg, Germany, 69115

Not Yet Recruiting

7

Zentrum für Psychische Gesundheit

Ingolstadt, Germany

Not Yet Recruiting

8

Dept. of Psychiatry, University Mainz

Mainz, Germany

Not Yet Recruiting

9

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

Mannheim, Germany, 68159

Actively Recruiting

10

Dept. of Psychiatry, LMU München

München, Germany

Not Yet Recruiting

11

Clinic for Psychiatry, Saarbrücken

Saarbrücken, Germany

Not Yet Recruiting

12

Klinik für Psychiatrie, Siegen

Siegen, Germany

Not Yet Recruiting

13

Dept. of Psychiatry, University Tübingen

Tübingen, Germany

Not Yet Recruiting

14

Dept. of Psychiatry I, Wiesloch

Wiesloch, Germany

Not Yet Recruiting

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Research Team

A

Alexander Sartorius, Prof

CONTACT

C

Christian R Wolf, Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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