E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10039628 |
E.1.2 | Term | Schizophrenia and other psychotic disorders |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
In this preparatory trial, we examine the feasibility of a foreseen large-scale randomized single (rater)-blind trial focused on (cost) effectiveness and safety of ECT vs. aripiprazole addition to CLZ in SSD patients insufficiently responsive to clozapine. The primary objective of the current feasibility trial is to assess the number of patients willing to be randomized, as well as the dropout rate during the study. The outcomes of the current feasibility study will be used to inform the design of the foreseen large-scale single(rater)-blind, randomized trial. |
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E.2.2 | Secondary objectives of the trial |
In this feasibility study, effect sizes of the outcome measures of the foreseen trial will therefore also be assessed (impact on QoL and cost-effectiveness). This is important to facilitate a power calculation for the number of patients that need to be included in the foreseen trial.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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’
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E.5 End points |
E.5.1 | Primary end point(s) |
number of patients willing to be randomized number of patients dropping out during study period
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Increase in EQ5D scores >20% reduction in PANSS score Reduction in CDSS total score clinical global impression-schizophrenia (CGI-S), recovery (Recovery Assessment Scale, RAS) and all-cause discontinuation |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Electroconvulsive therapy (ECT) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last patient out of 20 included patients. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |