Clozapine resistent schizophrenia therapy resistant psychosis
Conditions
Interventions
Arm 1: ECT addition to clozapine. Bilateral ECT will be started twice weekly
for 10 weeks and then in responders (i.e. those with either positive or total
symptom reductions >= 20%) tapered to once
Sponsors
Psychiatrie
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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)'.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoints of this feasibility study are 1. The proportion of patients willing to be randomized in this study. To that end, we will record the total number of eligible patients asked to participate in the trial and the number of eligible patients willing to be randomized who actually are randomized. Then we will compute the proportion of those willing to participate. 2. The number of participants we are able to recruit in 8 months* time. 3. the dropout rate of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, 4. effect sizes of the outcome measures of the foreseen trial will also be assessed. The primary outcome of the foreseen trial is: difference between the two arms in QoL measured using the EQ5D (https://euroqol.org/) from baseline until 10 weeks after treatment inception. Secondary outcome measures include: differences in PANSS (Positive and Negative Syndrome Scale; positive and negative symptoms analysed separately as well as total symptoms) from baseline to 10 and to 16 weeks between both arms; differences in response (>=20% reduction of total or positive symptoms on the PANSS), clinical global impression-schizophrenia (CGI-S), recovery (Recovery Assessment Scale, RAS), depressive symptoms (Calgary depression scale for schizophrenia, CDS), all-cause discontinuation, number of (S)AEs and Cost effectiveness assessed through questionnaires (Medical Consumption Questionnaire and Productivity Cost Questionnaire, iMCQ and iPCQ) from baseline to 10 and at 16 weeks. | — |
Countries
Netherlands
Outcome results
None listed