Survey on Pre-ECT Evaluation and ECT Application

Depression Clinical Trial

Official title:

Multicenter Assessment of Pre-Electroconvulsive Therapy (ECT) Evaluation and ECT Application

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04335916
• Other study ID #: KBC Zagreb
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Catatonia
• Depression
• Malignant Neuroleptic
• Neuroleptic Malignant Syndrome
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Suicidal Intention

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