EMECLO: the Electroconvulsive therapy vs. MEdication in patients with CLOzapine-refractory symptoms study

Phase 1

• Conditions: Schizophrenia; MedDRA version: 20.0Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-006333-19-NL
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-23
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•He/she currently uses CLZ, treated in inpatient or outpatient settings with a diagnosis of schizophrenia, psychotic disorder not otherwise specified or schizoaffective disorder, according to the DSM5 criteria,
•He/she is CR, meaning they failed to achieve Andreasen remission criteria, while on CLZ either for a minimum period of 12 weeks at a concentration = 350 Ug/L or lower with incomplete tolerance to CLZ.
•His/her age must be = 18 years old
•He/she must be able to speak and read Dutch
•He/she must be mentally competent and have decisional capacity with regard to a decision to participate in the current study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•prior treatment with ECT or ARI concomitantly with CLZ;
•known intolerance to ECT or ARI; and ARI or ECT-related contra-indications, i.e. kidney failure (GFR<30ml/min) and conditions predisposing to kidney failure (e.g. dehydration, infections and hypovolemic shock); recent CVA or intra cranial surgery; feochromocytome; current instable angina pectoris; disorders in the use of alcohol defined as > 2 reported consumptions daily and/or a gGT of over 60U/L and liver failure.
•pregnancy or being of child-bearing age without appropriate contraception.
•A history of Parkinson’s disease
•Admission to a psychiatric unit involuntarily in the context of a ‘crisis maatregel’

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified