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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036886

Enrollment

140

Registered

2025-05-14

Start date

2025-02-14

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F20.0

Interventions

Group 1: This is a German multi-center, observer-blind, randomized, and actively controlled parallel-group study to compare after a successful series of routine electroconvulsive therapy (ECT) the ove

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Current schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); BPRS total score > 45; History of clozapine resistant schizophrenia (CRS), which will include treatment-resistant schizophrenia with clozapine intolerance or absolute contraindications for clozapine

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The main purpose of the study is to show superiority of maintenance electroconvulsive therapy (mECT) plus treatment as usual (TAU) versus TAU only. The primary endpoint is the time to relapse for which relapse is defined as Brief Psychiatric Rating Scale (BPRS) =20% higher than individual BPRS at start of phase II 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 II or death. The BPRS is evaluated by an unblinded rater at the site and a blinded central rater. Hospital readmission is decided by unblinded non-study related staff. The first relapse decision is used for analysis. If the condition of a patient is worsening (assessed by unblinded staff), the BPRS assessment is videotaped for the evaluation by the blinded rater. The primary outcome will be assessed during the course of phase II of the study, which will last for 28 weeks. Regular visits are scheduled in week 3, 6, 10, 14, 19 and 28 of phase II.	—

Measure

Time frame

The main purpose of the study is to show superiority of maintenance electroconvulsive therapy (mECT) plus treatment as usual (TAU) versus TAU only. The primary endpoint is the time to relapse for which relapse is defined as Brief Psychiatric Rating Scale (BPRS) =20% higher than individual BPRS at start of phase II 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 II or death. The BPRS is evaluated by an unblinded rater at the site and a blinded central rater. Hospital readmission is decided by unblinded non-study related staff. The first relapse decision is used for analysis. If the condition of a patient is worsening (assessed by unblinded staff), the BPRS assessment is videotaped for the evaluation by the blinded rater. The primary outcome will be assessed during the course of phase II of the study, which will last for 28 weeks. Regular visits are scheduled in week 3, 6, 10, 14, 19 and 28 of phase II.

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Secondary

Measure	Time frame
Proportion of relapse free subjects at the end of phase II; BPRS; Global assessment of functioning (GAF); PANSS; HAMD; Northoff catatonia rating scale (NCRS-dv); Q-LES-Q-18; Self-Stigma of Mental Illness Scale – Short Form (SSMIS-SF); StigmaStress-Skala; MMSE; THINC-it	—

Countries

Germany

Contacts

Public ContactAlexander Sartorius

Zentralinstitut für Seelische Gesundheit

alexander.sartorius@zi-mannheim.de+4962117032913

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026