DepressionNCT04335916
Survey on Pre-ECT Evaluation and ECT Application
An observational study of Depression and Catatonia, run by Klinički Bolnički Centar Zagreb at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Catatonia, Schizophrenia
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2020to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Departments that provide pre-ECT assessment, ECT application or both in Europe
Who may be able to join
- departments that provide pre-ECT assessment
- departments that provide ECT application
- departments that provide both pre-ECT assessment and ECT application
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Klinički Bolnički Centar Zagreb
Zagreb, City of Zagreb, 10000
Sara Medved, +38512388888, vmedved@kif.hr
About this study
Official title: Multicenter Assessment of Pre-Electroconvulsive Therapy (ECT) Evaluation and ECT Application
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.
Read the 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.
- Conditions
- Depression, Catatonia, Schizophrenia, Schizoaffective Disorder, Suicidal Intention, Malignant Neuroleptic
- Keywords
- Electroconvulsive therapy, Pre-ECT evaluation
- Medical subject headings
- Depression, Catatonia, Schizophrenia, Psychotic Disorders, Neuroleptic Malignant Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinički Bolnički Centar Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335916
- Sponsor's protocol ID
- KBC Zagreb
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35462388
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Assessment of Pre-Electroconvulsive Therapy (ECT) Evaluation and ECT Application
- ClinicalTrials.gov ID
- NCT04335916
- Acronym / sponsor ID
- KBC Zagreb
- Conditions
- Depression, Catatonia, Schizophrenia, Schizoaffective Disorder, Suicidal Intention, Malignant Neuroleptic
- Keywords
- Electroconvulsive therapy, Pre-ECT evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Klinički Bolnički Centar ZagrebUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Departments that provide pre-ECT assessment, ECT application or both in Europe
Key inclusion criteria (3 listed)
- departments that provide pre-ECT assessment
- departments that provide ECT application
- departments that provide both pre-ECT assessment and ECT application
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pre-ECT evaluation data
Time frame: Baseline
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.
ECT administration data
Time frame: Baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Derived from this study: PubMed 35462388Medved 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Catatonia, run by Klinički Bolnički Centar Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Medved (+38512388888, smedved@kbc-zagreb.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pre-ECT evaluation data (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.