An interventional study of maintenance electroconvulsive therapy (mECT) in Schizophrenia and Treatment Resistant Schizophrenia, sponsored by Central Institute of Mental Health, Mannheim. Recruiting at 14 sites in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Central Institute of Mental Health, Mannheim · Not applicable, Interventional, and Treatment
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.
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.
53 studies on the registry are indexed under Schizophrenia, Treatment-Resistant; 22 are open to participants now.
This study's planned enrollment of 140 is above the median of 60 across 46 interventional studies indexed under Schizophrenia, Treatment-Resistant.
Browse Schizophrenia, Treatment-Resistant studies →Central Institute of Mental Health, Mannheim is the lead sponsor of 60 studies on the registry; 9 are open to participants now.
Compared within Schizophrenia, Treatment-Resistant, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Schizophrenia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
see Arms
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).
Time frame: 28 weeks (duration of PHASE 2)
Number of relapse free subjects
Number of relapse free subjects at the end of PHASE 2
Time frame: after 28 weeks, i.e. end of Phase 2
BPRS
BPRS: Brief Psychiatric Rating scale; higher is worse
Time frame: after 28 weeks, i.e. end of Phase 2
GAF:
GAF: Global Assessment of Functioning; higher is better
Time frame: after 28 weeks, i.e. end of Phase 2
SLSSWB:
SLSSWB: self-labeling, stigma stress and well-being (SLSSWB); descriptive subscales
Time frame: after 28 weeks, i.e. end of Phase 2
PANSS:
PANSS: Positive and Negative Syndrome Scale; higher is worse
Time frame: 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
Time frame: after 28 weeks, i.e. end of Phase 2
NCRS-dv:
NCRS-dv: Northoff catatonia rating scale (German version); higher is worse
Time frame: 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
Time frame: after 28 weeks, i.e. end of Phase 2
Cognition: MMSE:
MMSE: Mini Mental State Examination; higher is better
Time frame: after 28 weeks, i.e. end of Phase 2
THINC-it:
THINC-it: Tool for Cognitive Assessment and Measurement; green - amber - red (red means lower than 1 standard deviation worse than healthy control subjects)
Time frame: after 28 weeks, i.e. end of Phase 2
Plan to share: No
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Central Institute of Mental Health, Mannheim