Clinical trial NCT04335916: Survey on Pre-ECT Evaluation and ECT Application
Official title: Multicenter Assessment of Pre-Electroconvulsive Therapy (ECT) Evaluation and ECT Application
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Catatonia
Schizophrenia
Schizoaffective Disorder
Suicidal Intention
Malignant Neuroleptic
Keywords: Electroconvulsive therapy
Pre-ECT evaluation
Lead sponsor: Klinički Bolnički Centar Zagreb
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Departments that provide pre-ECT assessment, ECT application or both in Europe

Brief summary: The aim of this study is to identify specifics of pre-ECT assessments and ECT application in European psychiatric services. We will engage European centres that provide ECT for psychiatric patients and for psychiatric indications. It could bring better insights on current standards and possibly give some further improvements in the field of European ECT practices.

Detailed description: Electroconvulsive therapy (ECT) is an extremely important therapeutic method in the treatment of certain psychiatric conditions. Its' effect has been demonstrated in many clinical trials, and the indications for the use of ECT are clearly defined. Thus, the absolute indications for the use of ECT are catatonia and malignant neuroleptic syndrome, while the relative indications for ECT are therapy-resistant schizophrenia, depression and chronic suicidality. When the lead psychiatrist sets an indication for the use of ECT, pre-ECT evaluation is conducted. Although the pre-evaluation aims to assess the psychophysical condition of the patient and to determine the potential risks and possible side effects of such therapy, no clear algorithm of procedures is specified. There is no data on clear guidelines for the necessary processing prior to the application of ECT, both at national levels and globally. The assessment recommendations, however, are very broad, and most of them are focused on the ethical issues of applying ECT. The standardized pre-ECT evaluation would provide physicians and patients a systematic and evidence-based risk assessment and presumption of adverse reaction profiles.

Eligibility criteria: Inclusion Criteria:

* departments that provide pre-ECT assessment
* departments that provide ECT application
* departments that provide both pre-ECT assessment and ECT application

Exclusion Criteria:

* departments that used to provide either pre-ECT assessment or ECT application
* departments that refer patients for ECT but don't provide pre-ECT assessment

Primary outcomes:
measure: pre-ECT evaluation data
timeFrame: Baseline
measure: ECT administration data
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Klinički Bolnički Centar Zagreb
state: City Of Zagreb
Study officials:
References:
citation: Medved S, Zaja N, Gazdag G, Lengvenyte A, Morkl S, Mucci F, Ristic I, Jerotic S, Regente JF, Ivanovic I, Purisic A, Sasvary F, Sivasanker V, Ziblak A, Lookene M, Sienaert P, Szczegielniak A, Trancik P, Becirovic E, Koutsomitros T, Grech G, Tapoi C, Radmanovic B, Strohle A, Bajs Janovic M, Sartorius N. Preliminary Assessment of Pre-Electroconvulsive Therapy Evaluation Practices in European Countries: The Need for Guidelines. J ECT. 2022 Dec 1;38(4):230-237. doi: 10.1097/YCT.0000000000000854. Epub 2022 Apr 23.