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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04335916
Other study ID # KBC Zagreb
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date November 1, 2020

Study information

Verified date April 2020
Source Klinicki Bolnicki Centar Zagreb
Contact Sara Medved
Phone +38512388888
Email smedved@kbc-zagreb.hr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date November 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Croatia Klinicki Bolnicki Centar Zagreb Zagreb City Of Zagreb

Sponsors (1)

Lead Sponsor Collaborator
Klinicki Bolnicki Centar Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary pre-ECT evaluation data Data on pre-ECT evaluation collected with specially designed survey for this research.
Pre-ECT evaluation treatment includes are there written or agreed indications, inclusion and exclusion criteria and pre-ECT evaluation, the common neuropsychiatric and somatic evaluation for ECT candidate.
Baseline
Primary ECT administration data Data on ECT application collected with specially designed survey for this research. The survey examines the most common methods of applying ECT, provided education and the necessary legal and ethical codes. Baseline
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