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

Phase 4

Recruiting

Conditions: Clozapine resistent schizophrenia
therapy resistant psychosis
10039628

Registration Number: NL-OMON53720

Lead Sponsor: Psychiatrie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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 or discontinued CLZ and is willing to restart 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

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 nursing 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* or treatment with ECT or aripiprazole is provided as compulsory care
in the context of a *zorgmachtiging* (as described in the care plan (*zorg en
afstemmingsplan*) of the patient) or 'terbeschikkingstelling (TBS)'.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoints of this feasibility study are 1. The proportion of patients<br /><br>willing to be randomized in this study. To that end, we will record the total<br /><br>number of eligible patients asked to participate in the trial and the number of<br /><br>eligible patients willing to be randomized who actually are randomized. Then we<br /><br>will compute the proportion of those willing to participate. 2. The number of<br /><br>participants we are able to recruit in 8 months* time. 3. the dropout rate of<br /><br>the study. </p><br>

Secondary Outcome Measures