Mood DisordersACDCNCT05308056
Depth of Anesthesia During Electroconvulsive Therapy
An observational study of Mood Disorders and Psychotic Disorders, run by Region Örebro County at 1 site in Sweden.
Trial summary
Aim: To describe anesthetic depth using spectal edge frequency (SEF) and density spectral array (DSA) and its relation to treatment effect of electroconvulsive therapy (ECT). Study design: Observational study Primary outcomes: SEF, DSA and treatment effect of ECT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mood Disorders, Psychotic Disorders
- What is being tested?
- Depth of anesthesia monitor, SedLine® (Masimo, Irvine, CA, USA)
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteSweden
- Study dates
- 19 Apr 2022to 6 Feb 2023
- 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: All patients admitted for ECT during the study period
Who may be able to join
- Admitted for a course of ECT
Who cannot join
- Not able to attach electrodes for measurement of depth of anesthesia due to eg. skin condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Depth of Anetshesia During Electroconvulsive Therapy
Aim: To describe anesthetic depth using spectal edge frequency (SEF) and density spectral array (DSA) and its relation to treatment effect of electroconvulsive therapy (ECT).
Study design: Observational study Primary outcomes: SEF, DSA and treatment effect of ECT. Method: SEF and DSA si measured using a commercially available monitor for depth of anesthesia. Treatment effect of ECT will be evaluated using hemodynamic, electroencephalographic and clinical variables.
Read the detailed description
Background Electroconvulsive therapy (ECT) is an effective therapy for severe depression where an electric current is applied to the brain to induce an epileptic seizure (1). The success of ECT is dependent upon the degree and quality of epileptic activity (2). ECT is normally administered after administering a muscle relaxant to prevent the seizure activity from causing muculoskeletal injuries. To tolerate the muscle relaxant the entire procedure is performed under general anesthesia. Most hypnotics have anti-convulsant effects and therefore counteract the effects of ECT (3). This implies that deep anesthesia hinders an optimal treatment effect of ECT which is supported by observational data (4). This relation has been proven with lighter anesthesia measured through bispectral index (BIS) correlating to longer seizure duration (5). BIS is not optimized to estimate the depth of anesthesia under very dynamic anesthetic protocols as there is an inherent latency in the computation of the BIS value. Anesthesia for ECT generally consists only of induction and recovery with no stable anesthetic phase making BIS an inappropriate measure of anesthetic depth. Indices of anesthetic depth that are derived directly from the processed EEG-signal have a negligent latency and can therefore be used with more precision during anesthesia for ECT. Spectral edge frequency (SEF) is the frequency under which 95 % of the total amplitude of the EEG-signal is found and it decreases with increasing depths of anesthesia. The density spectral array (DSA) is a graphic representation of the frequency and amplitude of the EEG signal over time and it is possible to interpret the DSA in real time without extensive training. The SEF and DSA have not, to our knowledge, been previously tested during general anesthesia for ECT. In the postictal phase during recovery from ECT some patients become agitated and confused (6). This condition is not clearly defined in the literature but is commonly referred to as postictal agitation (PIA) and due to differing definitions the incidence is difficult to estimate. Incidences in the range of 10-20 % have been reported (7). In the post-operative period after cardiac surgery decreased regional cerebral oxygen saturation (SrcO2) has been linked to post-operative confusion (8). A possible link between decreased SrcO2 and PIA has not been studied before.
Aim
The aim of this research project is two-fold:
- To study the relation between anesthetic depth measured with SEF and DSA and the quality of epileptic activity during ECT.
- To study the relation between SrcO2 and PIA during ECT.
Hypotheses
- Lighter depths of anesthesia as measured by SEF and DSA have a positive correlation with epileptic seizure quality during ECT.
- SrcO2 during ECT has an inverse correlation with the incidence of PIA. Method Setting and recruitment The study will be performed at the ECT-unit of the university hospital in Örebro. General anesthesia is provided by a nurse specially trained in anesthesia and an anesthesiologist. ECT is provided by specially trained nurses and staff at the ECT-unit. Patients recover from the postictal phase in an adjacent recovery room. Patients undergoing ECT through the outpatient clinic will be recruited to the study.
Anesthetic protocol The protocol for anesthesia and ECT will be the same as is being used clinically at the ECT-unit. After preoxygenation anesthesia is induced using thiopental. After confirmation of adequate anesthetic depth (failure to respond to verbal command) suxamethonium is administered. Doses are chosen by the anesthesiologist. Patients are admitted to the recovery room when breathing spontaneously and can maintain a patent airway.
Data collection SEF and DSA will be measured continuously from before pre-oxygenation to admittance to the recovery room using a SedLine® (Masimo, Irvine, CA, USA) monitor. The monitor will be blinded during the procedure so as not to affect the staff in any way. SrcO2 will be measured using the same monitor during the same period. Data regarding the seizure duration will be gathered from the electronic patient records. The staff caring for the postictal patients will estimate the degree of PIA according to previously used numerical scale (9).Data will be presented as mean ± SD or median (IQR) according to their distribution. Statistical analysis will be performed using a logistic regression model adjusted for potential confounders such as type of psychiatric medication, age, bilateral or unilateral stimulation.
- Conditions
- Mood Disorders, Psychotic Disorders
- Being tested
- Depth of anesthesia monitor, SedLine® (Masimo, Irvine, CA, USA)
- Keywords
- General anesthesia, Electroencephalogram, Awareness, Depth of anesthesia, Depression
- Medical subject headings
- Mood Disorders, Psychotic Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depth of anesthesia monitor, SedLine® (Masimo, Irvine, CA, USA)Device
The device monitors the patient's electroencephalogram using electrodes applied to the forehead.
| Study group | Role | What they receive |
|---|---|---|
| ECT-patients | Patients receiving routine ECT. Receives: Device: Depth of anesthesia monitor, SedLine® (Masimo, Irvine, CA, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spectral edge frequency
The spectral edge frequency of the patients electroencephalogram
Measured: Monitored before, during and after ECT. Total monitoring time is apporximately 30 minutes per patient.
Change in density spectral array
The density spectral array of the patients electroencephalogram
Measured: Monitored before, during and after ECT. Total monitoring time is approximately 30 minutes per patient.
Duration of convulsive activity
Measures the duration of both motor and encephalographic convulsions directly following ECT.
Measured: Monitored immediately after administration of ECT.
Postictal supression
Measures the degree of encephalographic supression directly following ECT
Measured: Monitored immediately after administration of ECT.
Need for restimulation
Measures if there is a need for restimulation directly after evaluating the effect of an administered ECT.
Measured: Monitored immediately after administration of ECT.
Change in heart rate.
Mesaures the increase in heart rate directly following ECT.
Measured: Monitored immediately after administration of ECT.
Secondary outcomes (10)
Awareness
Patients will be asked if they can recall any part of the tratment from induction of anesthesia until administration of ECT.
Measured: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s.
Adverse effects of ECT
Occurence of adverse effects following ECT, evaluated using the CRPS-memory questionnaire.
Measured: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s.
Desaturation
Occurence of saturation <92 % at any point during anesthesia and ECT.
Measured: Monitored immediately before pre-oxygenation, during the entire ECT and until the patient has recovered. Approximately 1 hours of total monitoring time.
End-tidal CO2
Measurement of end-tidal CO2
Measured: During induction of general anesthesia
Change in depressive symtoms
Effect of ECT on patients' symptoms and quality of life. Evaluated using the self-asessed Montgomery Åsberg Depression Rating Scale (MADRS-S), 0-57 points. A higher score indicate more severe disease.
Measured: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
Clinical assessment of depth of anesthesia
The treating anesthesiologist will be asked to asses the depth of anesthesia. The anesthesiologist is asked after induction of general anesthesia. The terms too heavily sedated, too lightly sedated and adequate level of sedation is used.
Measured: Monitored immediately before pre-oxygenation, during the entire ECT and until the patient leaves the recovery ward. Approximately 1 hour of total monitoring time.
Regional cerebral oxygen saturation
Measured using near-infrared spectroscopy
Measured: Before, during and after anesthesia and ECT
Occurence of post-ictal agitation
Registered in the recovery ward following ECT. A scale using three levels of agitation is used by the recovery staff. Higher scores indicate increasing levels of agitation.
Measured: Monitored in the recovery suite
Change in quality of life
Effect of ECT on patients' symptoms and quality of life. Evaluated using EruroQol 5-Dimensions score (EQ-5D), each quiestion is scored 1-3 or 1-5 points. A higher score indicates worse health related problems.
Measured: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
Change in illness severity
Effect of ECT on patients' symptoms and quality of life. Evaluated using Clinial global impressions scale (CGI), each question is scored 1-7 points. A higher score indicates higher illness severity.
Measured: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start19 Apr 2022
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies 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
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308056
- Sponsor's protocol ID
- 276915
- Acronym
- ACDC
- Status last verified
- Feb 2022
- First submitted
- 23 Feb 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
UK ECT Review Group. Efficacy and safety of electroconvulsive therapy in depressive disorders: a systematic review and meta-analysis. Lancet. 2003 Mar 8;361(9360):799-808. doi: 10.1016/S0140-6736(03)12705-5.
PubMed 12642045Minelli A, Abate M, Zampieri E, Gainelli G, Trabucchi L, Segala M, Sartori R, Gennarelli M, Conca A, Bortolomasi M. Seizure Adequacy Markers and the Prediction of Electroconvulsive Therapy Response. J ECT. 2016 Jun;32(2):88-92. doi: 10.1097/YCT.0000000000000274.
PubMed 26397151Zolezzi M. Medication management during electroconvulsant therapy. Neuropsychiatr Dis Treat. 2016 Apr 19;12:931-9. doi: 10.2147/NDT.S100908. eCollection 2016.
PubMed 27143894Kronsell A, Nordenskjold A, Bell M, Amin R, Mittendorfer-Rutz E, Tiger M. The effect of anaesthetic dose on response and remission in electroconvulsive therapy for major depressive disorder: nationwide register-based cohort study. BJPsych Open. 2021 Mar 23;7(2):e71. doi: 10.1192/bjo.2021.31.
PubMed 33752777Guerrier G, Gianni MA. The effectiveness of BIS monitoring during electro-convulsive therapy: A systematic review and meta-analysis. J Clin Anesth. 2019 Dec;58:100-104. doi: 10.1016/j.jclinane.2019.05.006. Epub 2019 May 28.
PubMed 31151038Li X, Cheng N, Deng Y, Du J, Zhang M, Guo Y, Hei Z. Incidence and risk factors for postictal delirium in patients after electroconvulsive therapy in China. Asian J Psychiatr. 2020 Oct;53:102361. doi: 10.1016/j.ajp.2020.102361. Epub 2020 Aug 25. No abstract available.
PubMed 32890981Tsujii T, Uchida T, Suzuki T, Mimura M, Hirano J, Uchida H. Factors Associated With Delirium Following Electroconvulsive Therapy: A Systematic Review. J ECT. 2019 Dec;35(4):279-287. doi: 10.1097/YCT.0000000000000606.
PubMed 31764452Eertmans W, De Deyne C, Genbrugge C, Marcus B, Bouneb S, Beran M, Fret T, Gutermann H, Boer W, Vander Laenen M, Heylen R, Mesotten D, Vanelderen P, Jans F. Association between postoperative delirium and postoperative cerebral oxygen desaturation in older patients after cardiac surgery. Br J Anaesth. 2020 Feb;124(2):146-153. doi: 10.1016/j.bja.2019.09.042. Epub 2019 Dec 18.
PubMed 31862160
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depth of Anetshesia During Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT05308056
- Acronym / sponsor ID
- ACDC / 276915
- Conditions
- Mood Disorders, Psychotic Disorders
- Keywords
- General anesthesia, Electroencephalogram, Awareness, Depth of anesthesia, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 1 Apr 2022 (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.
Aim: To describe anesthetic depth using spectal edge frequency (SEF) and density spectral array (DSA) and its relation to treatment effect of electroconvulsive therapy (ECT).
Study design: Observational study Primary outcomes: SEF, DSA and treatment effect of ECT. Method: SEF and DSA si measured using a commercially available monitor for depth of anesthesia. Treatment effect of ECT will be evaluated using hemodynamic, electroencephalographic and clinical variables.
Detailed description
Background Electroconvulsive therapy (ECT) is an effective therapy for severe depression where an electric current is applied to the brain to induce an epileptic seizure (1). The success of ECT is dependent upon the degree and quality of epileptic activity (2). ECT is normally administered after administering a muscle relaxant to prevent the seizure activity from causing muculoskeletal injuries. To tolerate the muscle relaxant the entire procedure is performed under general anesthesia. Most hypnotics have anti-convulsant effects and therefore counteract the effects of ECT (3). This implies that deep anesthesia hinders an optimal treatment effect of ECT which is supported by observational data (4). This relation has been proven with lighter anesthesia measured through bispectral index (BIS) correlating to longer seizure duration (5). BIS is not optimized to estimate the depth of anesthesia under very dynamic anesthetic protocols as there is an inherent latency in the computation of the BIS value. Anesthesia for ECT generally consists only of induction and recovery with no stable anesthetic phase making BIS an inappropriate measure of anesthetic depth. Indices of anesthetic depth that are derived directly from the processed EEG-signal have a negligent latency and can therefore be used with more precision during anesthesia for ECT. Spectral edge frequency (SEF) is the frequency under which 95 % of the total amplitude of the EEG-signal is found and it decreases with increasing depths of anesthesia. The density spectral array (DSA) is a graphic representation of the frequency and amplitude of the EEG signal over time and it is possible to interpret the DSA in real time without extensive training. The SEF and DSA have not, to our knowledge, been previously tested during general anesthesia for ECT. In the postictal phase during recovery from ECT some patients become agitated and confused (6). This condition is not clearly defined in the literature but is commonly referred to as postictal agitation (PIA) and due to differing definitions the incidence is difficult to estimate. Incidences in the range of 10-20 % have been reported (7). In the post-operative period after cardiac surgery decreased regional cerebral oxygen saturation (SrcO2) has been linked to post-operative confusion (8). A possible link between decreased SrcO2 and PIA has not been studied before.
Aim
The aim of this research project is two-fold:
- To study the relation between anesthetic depth measured with SEF and DSA and the quality of epileptic activity during ECT.
- To study the relation between SrcO2 and PIA during ECT.
Hypotheses
- Lighter depths of anesthesia as measured by SEF and DSA have a positive correlation with epileptic seizure quality during ECT.
- SrcO2 during ECT has an inverse correlation with the incidence of PIA. Method Setting and recruitment The study will be performed at the ECT-unit of the university hospital in Örebro. General anesthesia is provided by a nurse specially trained in anesthesia and an anesthesiologist. ECT is provided by specially trained nurses and staff at the ECT-unit. Patients recover from the postictal phase in an adjacent recovery room. Patients undergoing ECT through the outpatient clinic will be recruited to the study.
Anesthetic protocol The protocol for anesthesia and ECT will be the same as is being used clinically at the ECT-unit. After preoxygenation anesthesia is induced using thiopental. After confirmation of adequate anesthetic depth (failure to respond to verbal command) suxamethonium is administered. Doses are chosen by the anesthesiologist. Patients are admitted to the recovery room when breathing spontaneously and can maintain a patent airway.
Data collection SEF and DSA will be measured continuously from before pre-oxygenation to admittance to the recovery room using a SedLine® (Masimo, Irvine, CA, USA) monitor. The monitor will be blinded during the procedure so as not to affect the staff in any way. SrcO2 will be measured using the same monitor during the same period. Data regarding the seizure duration will be gathered from the electronic patient records. The staff caring for the postictal patients will estimate the degree of PIA according to previously used numerical scale (9).Data will be presented as mean ± SD or median (IQR) according to their distribution. Statistical analysis will be performed using a logistic regression model adjusted for potential confounders such as type of psychiatric medication, age, bilateral or unilateral stimulation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECT-patients | – | Device: Depth of anesthesia monitor, SedLine® (Masimo, Irvine, CA, USA)Patients receiving routine ECT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted for ECT during the study period
Key inclusion criteria (1 listed)
- Admitted for a course of ECT
Key exclusion criteria (1 listed)
- Not able to attach electrodes for measurement of depth of anesthesia due to eg. skin condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depth of anesthesia monitor, SedLine® (Masimo, Irvine, CA, USA)The device monitors the patient's electroencephalogram using electrodes applied to the forehead. | Device | ECT-patients |
Primary outcome
Change in spectral edge frequency
Time frame: Monitored before, during and after ECT. Total monitoring time is apporximately 30 minutes per patient.
The spectral edge frequency of the patients electroencephalogram
Change in density spectral array
Time frame: Monitored before, during and after ECT. Total monitoring time is approximately 30 minutes per patient.
The density spectral array of the patients electroencephalogram
Duration of convulsive activity
Time frame: Monitored immediately after administration of ECT.
Measures the duration of both motor and encephalographic convulsions directly following ECT.
Postictal supression
Time frame: Monitored immediately after administration of ECT.
Measures the degree of encephalographic supression directly following ECT
Need for restimulation
Time frame: Monitored immediately after administration of ECT.
Measures if there is a need for restimulation directly after evaluating the effect of an administered ECT.
Change in heart rate.
Time frame: Monitored immediately after administration of ECT.
Mesaures the increase in heart rate directly following ECT.
10 secondary outcomes
Awareness
Time frame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s.
Adverse effects of ECT
Time frame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s.
Desaturation
Time frame: Monitored immediately before pre-oxygenation, during the entire ECT and until the patient has recovered. Approximately 1 hours of total monitoring time.
End-tidal CO2
Time frame: During induction of general anesthesia
Change in depressive symtoms
Time frame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
Clinical assessment of depth of anesthesia
Time frame: Monitored immediately before pre-oxygenation, during the entire ECT and until the patient leaves the recovery ward. Approximately 1 hour of total monitoring time.
Regional cerebral oxygen saturation
Time frame: Before, during and after anesthesia and ECT
Occurence of post-ictal agitation
Time frame: Monitored in the recovery suite
Change in quality of life
Time frame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
Change in illness severity
Time frame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Background: PubMed 12642045UK ECT Review Group. Efficacy and safety of electroconvulsive therapy in depressive disorders: a systematic review and meta-analysis. Lancet. 2003 Mar 8;361(9360):799-808. doi: 10.1016/S0140-6736(03)12705-5.
- Background: PubMed 26397151Minelli A, Abate M, Zampieri E, Gainelli G, Trabucchi L, Segala M, Sartori R, Gennarelli M, Conca A, Bortolomasi M. Seizure Adequacy Markers and the Prediction of Electroconvulsive Therapy Response. J ECT. 2016 Jun;32(2):88-92. doi: 10.1097/YCT.0000000000000274.
- Background: PubMed 27143894Zolezzi M. Medication management during electroconvulsant therapy. Neuropsychiatr Dis Treat. 2016 Apr 19;12:931-9. doi: 10.2147/NDT.S100908. eCollection 2016.
- Background: PubMed 33752777Kronsell A, Nordenskjold A, Bell M, Amin R, Mittendorfer-Rutz E, Tiger M. The effect of anaesthetic dose on response and remission in electroconvulsive therapy for major depressive disorder: nationwide register-based cohort study. BJPsych Open. 2021 Mar 23;7(2):e71. doi: 10.1192/bjo.2021.31.
- Background: PubMed 31151038Guerrier G, Gianni MA. The effectiveness of BIS monitoring during electro-convulsive therapy: A systematic review and meta-analysis. J Clin Anesth. 2019 Dec;58:100-104. doi: 10.1016/j.jclinane.2019.05.006. Epub 2019 May 28.
- Background: PubMed 32890981Li X, Cheng N, Deng Y, Du J, Zhang M, Guo Y, Hei Z. Incidence and risk factors for postictal delirium in patients after electroconvulsive therapy in China. Asian J Psychiatr. 2020 Oct;53:102361. doi: 10.1016/j.ajp.2020.102361. Epub 2020 Aug 25. No abstract available.
- Background: PubMed 31764452Tsujii T, Uchida T, Suzuki T, Mimura M, Hirano J, Uchida H. Factors Associated With Delirium Following Electroconvulsive Therapy: A Systematic Review. J ECT. 2019 Dec;35(4):279-287. doi: 10.1097/YCT.0000000000000606.
- Background: PubMed 31862160Eertmans W, De Deyne C, Genbrugge C, Marcus B, Bouneb S, Beran M, Fret T, Gutermann H, Boer W, Vander Laenen M, Heylen R, Mesotten D, Vanelderen P, Jans F. Association between postoperative delirium and postoperative cerebral oxygen desaturation in older patients after cardiac surgery. Br J Anaesth. 2020 Feb;124(2):146-153. doi: 10.1016/j.bja.2019.09.042. Epub 2019 Dec 18.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mood Disorders and Psychotic Disorders, run by Region Örebro County at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Mar 2023. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spectral edge frequency (time frame: Monitored before, during and after ECT. Total monitoring time is apporximately 30 minutes per patient.). The study lists 6 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 NCT05308056, which also lists 8 linked publications.
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 30 Mar 2023.